510(k) K013425 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
| Applicant | Philips Medical Systems, Seattle WA, US |
| Decision | Substantially Equivalent, Jan 14, 2002 |
| Received | Oct 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2010 | Philips Medical Systems HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode.
The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Man Terminated |
MKJ | None listed |
| Nov 29, 2010 | Philips Medical Systems HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge.
The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufa Terminated |
MKJ | None listed |
| Nov 29, 2010 | Philips Medical Systems HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode.
The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manu Terminated |
MKJ | None listed |
| Nov 29, 2010 | Philips Medical Systems HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual charge.
The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufac Terminated |
MKJ | None listed |
| Nov 29, 2010 | Philips Medical Systems HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Car Terminated |
MKJ | None listed |
| Nov 29, 2010 | Philips Medical Systems HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emerge Terminated |
MKJ | None listed |
| 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.