510(k) K080421 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEART SYNC, MODELS C-100 AND T-100
| Applicant | Heart Sync, LLC, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 29, 2008 |
| Received | Feb 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2014 | Heart Sync, Inc. ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use d Terminated |
MKJ | None listed |
| Dec 24, 2014 | Heart Sync, Inc. ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended f Terminated |
MKJ | None listed |
| Dec 24, 2014 | Heart Sync, Inc. ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use Terminated |
MKJ | None listed |
| Dec 24, 2014 | Heart Sync, Inc. ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use du Terminated |
MKJ | None listed |
| Dec 24, 2014 | Heart Sync, Inc. ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended fo Terminated |
MKJ | None listed |
| May 30, 2013 | Heart Sync, Inc Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes
Used in connection with a defibrill Terminated |
LDF | None listed |
| May 30, 2013 | Heart Sync, Inc Vermed, Inc Radiotransparent Defibrillation Electrodes
Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes.
Used in connection with a defibrillator to deli Terminated |
LDF | None listed |
| Apr 12, 2011 | Heart Sync, Inc Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242.
Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for Terminated |
MLN | None listed |
| Apr 12, 2011 | Heart Sync, Inc Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO.
Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for si Terminated |
MLN | None listed |
| Feb 18, 2011 | Heart Sync, Inc Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI.
The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillat Terminated |
MLN | None listed |
| Feb 18, 2011 | Heart Sync, Inc Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI.
The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and moni Terminated |
MLN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.