510(k) K973486 ยท MKJ Automated External Defibrillators (Non-Wearable)
LIFE PAK 12
| Applicant | Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Sep 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2011 | Physio Control, Inc. 12-lead ECG Cable Assembly contains the following cable and attachments:
Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated Terminated |
MKJ | None listed |
| 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 |
| Feb 5, 2003 | Medtronic Physio Control Corp LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to exte Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.