The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Model 78720ac Arrhythmia Monit Sys.
Device ID | K913451 |
510k Number | K913451 |
Device Name: | HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS |
Classification | Detector And Alarm, Arrhythmia |
Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Contact | William C Kole |
Correspondent | William C Kole 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 | 1991-08-02 |
Decision Date | 1991-10-31 |