The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstart Mrx With Q-cpr Option, Models M3535a Or M3536a.
| Device ID | K051134 |
| 510k Number | K051134 |
| Device Name: | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon PHILIPS MEDICAL SYSTEMS 49 PLAIN STREET North Attleboro, MA 02760 |
| 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 | MWI |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-03 |
| Decision Date | 2005-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838035256 | K051134 | 000 |
| 00884838015104 | K051134 | 000 |
| 00884838002791 | K051134 | 000 |
| 20884838015108 | K051134 | 000 |