The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Heartstart Xl+, Philips Heartstart External Paddles, Philips Multifunction Electrodes.
| Device ID | K110825 |
| 510k Number | K110825 |
| Device Name: | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Product Code | MKJ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DXN |
| Subsequent Product Code | LDD |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2012-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838023680 | K110825 | 000 |
| 20884838015245 | K110825 | 000 |