DRRClass II
Amplifier And Signal Conditioner, Biopotential
Cardiovascular · 21 CFR 870.2050
MDR events6All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances24All time
Recent MDR events
6 adverse event reports on file
- GE CARDIOLABJan 8, 2008MalfunctionGeneral ElectricMW5004932
- SUPERPAC BATTERYJun 16, 2005MalfunctionMrl, Inc. A Welch Allyn Company1418729-2005-00082
- CARDIO LABMar 31, 2005MalfunctionGeneral ElectricMW1035079
- PRUKA CARDIOLABOct 5, 2000InjuryGe Marquette300214
- CARDIOLAB SYSTEMOct 5, 2000MalfunctionGe Marquette Medical Systems2124823-2000-00047
- PRUKA CARDIOLABSep 15, 2000InjuryGe/marquetteMW1019932
Event type breakdown
Malfunction4
Injury2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
24 clearances for this product code
- Biocheck, Inc.Dec 19, 2002
K022660 · BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
- Quinton Electrophysiology Corp.Dec 29, 1997
K971570 · EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
- Quinton Electrophysiology Corp.Apr 30, 1993
K925346 · EP AMP, MODEL #901
- Mennen Medical, Inc.Jan 28, 1992
K914381 · HORIZON 9000/HIS OPTION AMPLIFIER
- Gould, Inc.Jul 22, 1991
K911935 · CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
- Prucka Engineering, Inc.Apr 12, 1991
K910307 · CARDIOLAB AMPLIFIER MODULE (CAM)
- Astro-Med, Inc.Sep 18, 1989
K894735 · ASC-952 PHYSIOLOGICAL AMPLIFIER
- Astro-Med, Inc.Aug 3, 1989
K894161 · ASC-950 ECG AMPLIFIER