510(k) K003819 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
| Applicant | Agilent Technologies, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Dec 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode. Terminated |
MKJ | None listed |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model:
M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode. Terminated |
MKJ | None listed |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model:
M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge. Terminated |
MKJ | None listed |
| Nov 26, 2010 | Philips Medical Systems HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge. Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.