The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Heartstart Fr3 Automated External Defibrillator.
| Device ID | K130684 |
| 510k Number | K130684 |
| Device Name: | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 -3003 |
| Contact | Nancy Burke |
| Correspondent | Nancy Burke PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 -3003 |
| Product Code | MKJ |
| Subsequent Product Code | DPS |
| Subsequent Product Code | LDD |
| Subsequent Product Code | LIX |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838050006 | K130684 | 000 |
| 00884838049949 | K130684 | 000 |
| 00884838034655 | K130684 | 000 |
| 00884838034648 | K130684 | 000 |