The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Heartstream Electrode Adapter.
| Device ID | K984286 |
| 510k Number | K984286 |
| Device Name: | HEARTSTREAM ELECTRODE ADAPTER |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEWLETT-PACKARD CO. 2401 FOURTH AVENUE, SUITE 500 Seattle, WA 98121 |
| Contact | William D Jordan |
| Correspondent | William D Jordan HEWLETT-PACKARD CO. 2401 FOURTH AVENUE, SUITE 500 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 | 1998-12-01 |
| Decision Date | 1998-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838037977 | K984286 | 000 |