510(k) K895379 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
| Applicant | Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Feb 26, 1990 |
| Received | Aug 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Physio Control, Inc. Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12 and 20. PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P. Terminated |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.