The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Lifepak 15 Monitor/defibrillator.
| Device ID | K142430 |
| 510k Number | K142430 |
| Device Name: | LIFEPAK 15 Monitor/defibrillator |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. Redmond, WA 98073 -9706 |
| Contact | Sylvia Lemke |
| Correspondent | Sylvia Lemke PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. Redmond, WA 98073 -9706 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883873994429 | K142430 | 000 |
| 00883873832554 | K142430 | 000 |
| 00883873832561 | K142430 | 000 |
| 00883873832578 | K142430 | 000 |
| 00883873836330 | K142430 | 000 |
| 00883873869444 | K142430 | 000 |
| 00883873869451 | K142430 | 000 |
| 00883873869468 | K142430 | 000 |
| 00883873907252 | K142430 | 000 |
| 00883873940112 | K142430 | 000 |
| 00883873940204 | K142430 | 000 |
| 00883873940464 | K142430 | 000 |
| 00883873940471 | K142430 | 000 |
| 00883873940488 | K142430 | 000 |
| 00883873940495 | K142430 | 000 |
| 00883873940501 | K142430 | 000 |
| 00883873940518 | K142430 | 000 |
| 00883873989098 | K142430 | 000 |
| 00681490587853 | K142430 | 000 |