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 |