The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Heartstart Frx Defibrillator, Model 861304.
| Device ID | K050004 |
| 510k Number | K050004 |
| Device Name: | PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 2301 FIFTH AVE., SUITE 200 Seattle, WA 98121 |
| Contact | Tisha Treherne |
| Correspondent | Tisha Treherne PHILIPS MEDICAL SYSTEMS 2301 FIFTH AVE., SUITE 200 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-02 |
| Decision Date | 2005-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080768 | K050004 | 000 |
| 00884838050716 | K050004 | 000 |
| 00884838050709 | K050004 | 000 |
| 00884838038004 | K050004 | 000 |
| 00884838023802 | K050004 | 000 |
| 00884838023703 | K050004 | 000 |
| 00884838006560 | K050004 | 000 |