FDA Device Intelligence
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Tester, Defibrillator

FDA product code DRL · Class 2 · Cardiovascular

15
Registered devices
5
Adverse events
1
Recalls
19
510(k) clearances

Devices with this code

BC Biomedical Defibrillator Analyzer Variable Load — BC GROUP INTERNATIONAL, INC.Impulse 4000 — FLUKE ELECTRONICS CORPORATIONDefibrillator / Transcutaneous Pacemaker Analyzer — NETECH CORPORATIONDatrend — Datrend Systems IncImpulse 7010 — FLUKE ELECTRONICS CORPORATIONGossen Metrawatt SECULIFE — BC GROUP INTERNATIONAL, INC.Gossen Metrawatt SECULIFE — BC GROUP INTERNATIONAL, INC.Defibrillator Analyzer — NETECH CORPORATIONBC Biomedical Defibrillator Analyzer — BC GROUP INTERNATIONAL, INC.Impulse 7000DP — FLUKE ELECTRONICS CORPORATIONGossen Metrawatt SECULIFE — BC GROUP INTERNATIONAL, INC.Impulse 6000D — FLUKE ELECTRONICS CORPORATIONZAP GUARD — GUARDIAN ANGEL PRODUCTS INCZAP GUARD — GUARDIAN ANGEL PRODUCTS INCBC Biomedical Defibrillator Analyzer — BC GROUP INTERNATIONAL, INC.

Recent recalls

DateFirmReason
2015-10-28BC Group International IncDevice is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.