The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Cc Arhythmis Monitoring Option.
Device ID | K923747 |
510k Number | K923747 |
Device Name: | CC ARHYTHMIS MONITORING OPTION |
Classification | Detector And Alarm, Arrhythmia |
Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Contact | Peter W Childs |
Correspondent | Peter W Childs 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 | 1992-07-09 |
Decision Date | 1993-07-20 |