The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp M1205a Omnicare Component Transport Monitoring System Model 24.
Device ID | K950821 |
510k Number | K950821 |
Device Name: | HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 |
Classification | Detector And Alarm, Arrhythmia |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | Ray Stelting |
Correspondent | Ray Stelting HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-23 |
Decision Date | 1995-10-03 |