The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstart Xl+defibrillator/monitor With End-tidal Carbon Dioxide Monitoring.
| Device ID | K133659 |
| 510k Number | K133659 |
| Device Name: | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT WAY Bothell, WA 98021 |
| Contact | John Pardo |
| Correspondent | Carlene Comrie PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT WAY Bothell, WA 98021 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DXN |
| Subsequent Product Code | LDD |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-27 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838037946 | K133659 | 000 |