The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Heartstart Mrx, Model M3535a.
| Device ID | K040404 |
| 510k Number | K040404 |
| Device Name: | HEARTSTART MRX, MODEL M3535A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. MS 0222 Andover, MA 01810 -1099 |
| Contact | Peter Ohanian |
| Correspondent | Peter Ohanian PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. MS 0222 Andover, MA 01810 -1099 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-04 |
| Summary: | summary |