The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Star St And Arrhhythmia Software.
Device ID | K964122 |
510k Number | K964122 |
Device Name: | HP STAR ST AND ARRHHYTHMIA SOFTWARE |
Classification | Detector And Alarm, Arrhythmia |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 |
Contact | Ray Stelting |
Correspondent | Ray Stelting HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-15 |
Decision Date | 1997-01-08 |
Summary: | summary |