Stimulator, Photic, Evoked Response
Neurology · 21 CFR 882.1890
Recent MDR events
11 adverse event reports on file
- NATUS PHOTIC STIM KITJan 17, 2025MalfunctionNatus Medical Incorporated Dba Excel-tech Ltd.9612330-2025-00001
- NATUS PHOTIC STIM KITApr 6, 2022MalfunctionNatus Medical Incorporated9612330-2022-00019
- NATUS PHOTIC STIM KITFeb 16, 2022MalfunctionNatus Medical Incorporated9612330-2022-00011
- PHOTIC STIMNov 28, 2018MalfunctionNatus Medical Inc. Dba Excle-tech Ltd (xltek)9612330-2018-00022
- NATUS PHOTIC STIM KITNov 15, 2018MalfunctionNatus Medical Inc. Dba Excle-tech Ltd (xltek)9612330-2018-00018
- CASCADE EMG/EP/EEG IOMSep 21, 2016MalfunctionCadwell Industries, Inc.5966099
- CASCADE EMG/EP/EEG IOMSep 15, 2016MalfunctionCadwell Industries, Inc.5952204
- CASCADE ELITEMar 21, 2014MalfunctionCadwell Laboratories, Inc.3752923
- CASCADE ELITEMar 16, 2012Cadwell Laboratories Inc.2497872
- EPOCH XPSep 28, 2010Axon Systems1865027
Event type breakdown
Recalls
3 recall events for this product code
- Natus Medical IncorporatedTerminatedFeb 9, 2015
EPWorks software used in the Protektor 32
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
Z-1067-2015 · View FDA record ↗ - Diopsys, Inc.TerminatedApr 26, 2010
Diopsys Inc., Enfant Pediatric VEP Vision Testing System,
The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.
Z-1437-2010 · View FDA record ↗ - Diopsys IncTerminatedNov 6, 2004
The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840.
The firm established no medical device quality system, no established quality plan and no established quality procedures.
Z-0186-05 · View FDA record ↗
Registered firms
76 firms currently registered for this product code
Diopsys Inc.
Middletown, PA, US
Fideltronik Poland Sp. Z O.o.
Sucha Beskidzka Malopolskie, PL
Xian Friendship Medical Electronics Co., Ltd.
Xi'an Shaanxi, CN
Inomed Medizintechnik Gmbh
EMMENDINGEN Baden-Wurttemberg, DE
Cadwell Industries, Inc.
KENNEWICK, WA, US
Natus Neurology Incorporated
Middleton, WI, US
Neurosoft Ltd
Ivanovo Ivanovskaya Oblast', RU
Bee Systems, Inc
Beaverton, OR, US
Lifelines Neuro Company
Louisville, KY, US
Natus Medical Incorporated Dba Excel-tech Ltd. (xltek)
OAKVILLE Ontario, CA
Nihon Kohden Corporation - Tokorozawa Establishment Advanced Technology Center
Tokorozawa Saitama, JP
Natus Manufacturing Limited
GORT, Co. Galway, IE
Nihon Kohden Tomioka Corporation
Gunma Tokyo, JP
Paul E. Danchell A/s
Jyderup Sjalland, DK
Nihon Kohden Corp.
SHINJUKU-KU Tokyo, JP
Metrovision Sas
Perenchies Nord, FR
Konan Medical Usa, Inc.
Irvine, CA, US
Intelligent Hearing Systems Corp.
MIAMI, FL, US
Lkc Technologies, Inc.
Germantown, MD, US
Nihon Kohden America Fulfillment Center
Foothill Ranch, CA, US
Chemigraphic Ltd
Crawley West Sussex, GB
Diagnosys Llc
Lowell, MA, US
510(k) clearances
49 clearances for this product code
- Diagnosys, LLCNov 22, 2022
K221471 · E3 and Profile
- MetrovisionNov 21, 2022
K212936 · Vision Monitor- MonCvONE
- Micromed S.P.A.Sep 23, 2021
K211974 · LED PHOTIC System
- MetrovisionJul 26, 2021
K211643 · Vision Monitor - MonpackONE
- Cryptych Pty, Ltd.Apr 23, 2020
K200705 · Nurochek System
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)Jun 15, 2018
K173936 · Natus Photic Stimulator
- Lkc Technologies, Inc.May 19, 2015
K142567 · RETeval Visual Electrodiagnostic Device
- Anschel Technology, Inc.Jun 6, 2012
K113785 · ADHERENT VISUAL STIMULATOR GOGGLES