HCSClass II

Device, Temperature Measurement, Direct Contact, Powered

Neurology · 21 CFR 882.1570

MDR events8All time

Recalls0All time

Registered firms0Currently listed

510(k) clearances8All time

Recent MDR events

8 adverse event reports on file

THERMISTOR 400 MON-A-THERM CABLE 400 TMJul 19, 2017
InjurySinbon Electronics-jiangyin2936999-2017-05334
REUSABLE HEATER WIREFeb 21, 2007
MalfunctionFisher & Paykel Healthcare Ltd.9611451-2007-00036
900MR510 REUSABLE HEATER WIREJan 17, 2007
MalfunctionFisher & Paykel Healthcare, Ltd.9611451-2007-00005
RIGHT ANGLE AIRWAY PRONEApr 27, 2006
MalfunctionFisher & Paykel Healthcare, Ltd.9611451-2006-00005
DCS 18 2X4 HELICAL FILLNov 10, 2005
InjuryCordis Neurovascular, Inc.1058196-2005-00373
NEO-THERMAug 22, 1999
MalfunctionRespiratory Support Products, Inc.MW1017034
NEO-THERM SKIN TEMP SENSORMar 4, 1999
Smiths Industries Medical Systems, Inc.MW1015851
FISHER-PAYKEL TEMPERATURE PROBEMar 5, 1992
InjuryFisher-paykel (distributed By Baxter)278

Event type breakdown

Malfunction4

Injury3

Unspecified1

Most-reported manufacturers

Fisher & Paykel Healthcare, Ltd.2 Cordis Neurovascular, Inc.1 Fisher & Paykel Healthcare Ltd.1 Fisher-paykel (distributed By Baxter)1 Respiratory Support Products, Inc.1 Sinbon Electronics-jiangyin1 Smiths Industries Medical Systems, Inc.1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

8 clearances for this product code