The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Heartstart Mrx Monitor/defibrillator.
| Device ID | K062233 |
| 510k Number | K062233 |
| Device Name: | HEARTSTART MRX MONITOR/DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 3000 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Contact | Michael J Doyle |
| Correspondent | Michael J Doyle PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 3000 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DXN |
| Subsequent Product Code | LDD |
| Subsequent Product Code | LIX |
| Subsequent Product Code | MSX |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838015207 | K062233 | 000 |