510(k) K182503 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
| Applicant | Physio-Control, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jun 3, 2019 |
| Received | Sep 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2024 | Physio-Control, Inc. STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, s Open, Classified |
LDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.