510(k) K951593 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
LIFEPAK 11
| Applicant | Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 29, 1995 |
| Received | Apr 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2008 | Physio Control, Inc. FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 1 Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.