The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Heartstart Fr2+ Automated External Defibrillator, Models M3860a, M3861a, M3840a, M3841a.
| Device ID | K051632 |
| 510k Number | K051632 |
| Device Name: | PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 2301 FIFTH AVE., SUITE 200 Seattle, WA 98121 |
| Contact | Tamara Yount |
| Correspondent | Tamara Yount PHILIPS MEDICAL SYSTEMS 2301 FIFTH AVE., SUITE 200 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838050730 | K051632 | 000 |
| 00884838050723 | K051632 | 000 |
| 00884838050396 | K051632 | 000 |
| 00884838050389 | K051632 | 000 |
| 00884838023833 | K051632 | 000 |
| 00884838023826 | K051632 | 000 |
| 00884838023789 | K051632 | 000 |