The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstream/heartstart Fr2 Aed Ecg Cable, Models M3860a, M3861a, M3840a, M3841a.
| Device ID | K013425 |
| 510k Number | K013425 |
| Device Name: | HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-16 |
| Decision Date | 2002-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838049963 | K013425 | 000 |
| 00884838049956 | K013425 | 000 |