Medical Device Manufacturer · US , Seattle , WA

Heartstream, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1996

Recent clearances: HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX), FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heartstream, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Sep 25, 1997

HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH...

Cardiovascular · 90d

Cleared Sep 10, 1996

FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS

Cardiovascular · 274d