The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp M2600a Omnicare Telemetry System Model M2600a.
Device ID | K961165 |
510k Number | K961165 |
Device Name: | HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A |
Classification | Detector And Alarm, Arrhythmia |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Ray Sterling |
Correspondent | Ray Sterling HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-25 |
Decision Date | 1996-10-10 |
Summary: | summary |