The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstart Mrx, Model M3535a.
| Device ID | K031187 |
| 510k Number | K031187 |
| Device Name: | HEARTSTART MRX, MODEL M3535A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Peter Ohanian |
| Correspondent | Peter Ohanian PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MKJ |
| Subsequent Product Code | DRO |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-15 |
| Decision Date | 2003-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838045927 | K031187 | 000 |
| 20884838015184 | K031187 | 000 |
| 00884838000018 | K031187 | 000 |
| 00884838002753 | K031187 | 000 |
| 00884838002777 | K031187 | 000 |
| 00884838002784 | K031187 | 000 |
| 00884838006652 | K031187 | 000 |
| 00884838006676 | K031187 | 000 |
| 00884838006683 | K031187 | 000 |
| 00884838015180 | K031187 | 000 |
| 00884838021914 | K031187 | 000 |
| 00884838021921 | K031187 | 000 |
| 00884838021938 | K031187 | 000 |
| 00884838023659 | K031187 | 000 |
| 00884838027961 | K031187 | 000 |
| 00884838045903 | K031187 | 000 |
| 00884838045910 | K031187 | 000 |
| 20884838002757 | K031187 | 000 |