The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstream Xl Defibrillator/monitor, Model #m4735a.
| Device ID | K021453 |
| 510k Number | K021453 |
| Device Name: | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Richard J Petersen |
| Correspondent | Richard J Petersen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838003354 | K021453 | 000 |
| 00884838003347 | K021453 | 000 |
| 00884838003330 | K021453 | 000 |
| 00884838003323 | K021453 | 000 |
| 00884838002760 | K021453 | 000 |
| 00884838002111 | K021453 | 000 |
| 00884838002104 | K021453 | 000 |
| 00884838002098 | K021453 | 000 |
| 00884838002081 | K021453 | 000 |