DRLClass II
Tester, Defibrillator
Cardiovascular · 21 CFR 870.5325
MDR events5All time
Recalls1All time
Registered firms6Currently listed
510(k) clearances19All time
Recent MDR events
5 adverse event reports on file
- FLUKE BIOMEDICALJul 8, 2026MalfunctionFluke Biomedical0002921581-2026-00001
- IMPULSE 7000DPFeb 26, 2013MalfunctionFluke Biomedical2921581-2013-00001
- IMPULSE 7000DPFeb 26, 2013MalfunctionFluke Biomedical2921581-2013-00002
- HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATIONMar 6, 2009MalfunctionPhysio-control, Inc.3015876-2009-00270
- ZAP-GUARDJan 16, 1998MalfunctionGuardian Angel Products, Inc.MW1012826
Event type breakdown
Malfunction5
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
6 firms currently registered for this product code
510(k) clearances
19 clearances for this product code
- Netech CorporationAug 28, 2019
K190437 · Delta 3300
- Seaward GroupDec 14, 2018
K182905 · UniPulse
- Bc Group International, Inc.Dec 21, 2015
K153210 · Defibrillator Analyzer Variable Load
- Bc Group International, Inc.Feb 8, 2011
K110192 · DEFIBRILLATOR ANALYZER - DA-2006P
- Fluke BiomedicalDec 24, 2008
K083347 · IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
- Fluke BiomedicalJan 28, 2008
K072114 · IMPULSE 6000D/7000DP
- Datrend Systems, Inc.Jan 25, 2007
K062099 · PHASE 3, MODEL DT-1
- Guardian Angel Products, Inc.Jul 11, 2003
K030547 · MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE