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 | K111693 |
| 510k Number | K111693 |
| Device Name: | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 2301 5TH AVENUE, SUITE 200 Seattle, WA 98121 -1825 |
| Contact | Tamara Yount |
| Correspondent | Tamara Yount PHILIPS MEDICAL SYSTEMS 2301 5TH AVENUE, SUITE 200 Seattle, WA 98121 -1825 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-16 |
| Decision Date | 2011-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838055711 | K111693 | 000 |
| 00884838041547 | K111693 | 000 |
| 00884838048607 | K111693 | 000 |
| 00884838049987 | K111693 | 000 |
| 00884838049994 | K111693 | 000 |
| 00884838051416 | K111693 | 000 |
| 00884838051423 | K111693 | 000 |
| 00884838051430 | K111693 | 000 |
| 00884838051447 | K111693 | 000 |
| 00884838051454 | K111693 | 000 |
| 00884838051461 | K111693 | 000 |
| 00884838055681 | K111693 | 000 |
| 00884838055704 | K111693 | 000 |
| 00884838023857 | K111693 | 000 |