510(k) K103159 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
CARDIO MED MODEL A102, H104, O101, P103, AND Z100
| Applicant | Cardio Medical Products, Inc., Rockaway NJ, US |
| Decision | Substantially Equivalent, Jan 11, 2011 |
| Received | Oct 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2013 | Cardio Medical Products Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only
Manufactured for Cardio Medical Products 385 Franklin Avenue, Sui Terminated |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.