The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstreamfr2 Aed With M3848a And M3849a, Models M3860a, M3861, M3840a, M3841a.
| Device ID | K014157 |
| 510k Number | K014157 |
| Device Name: | HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 |
| Contact | Tamara Yount |
| Correspondent | Tamara Yount PHILIPS MEDICAL SYSTEMS 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-01-17 |
| Summary: | summary |