The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Heartstream Xlt Defibrillator/monitor, Ac Charger, Dc Charger, Data Card, Single Bay Adapter, Defibrillator Pads Cable.
| Device ID | K992543 |
| 510k Number | K992543 |
| Device Name: | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEWLETT-PACKARD CO. 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 -1436 |
| Contact | Teresa Skarr |
| Correspondent | Teresa Skarr HEWLETT-PACKARD CO. 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 -1436 |
| Product Code | MKJ |
| Subsequent Product Code | DRO |
| Subsequent Product Code | LDD |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 2000-05-18 |
| Summary: | summary |