The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Modified Monitoring System Models M1175a & M1176a.
| Device ID | K910490 |
| 510k Number | K910490 |
| Device Name: | MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Contact | Richard Beebe |
| Correspondent | Richard Beebe HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-04-26 |