The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Portable Patient Monitor.
Device ID | K945134 |
510k Number | K945134 |
Device Name: | PORTABLE PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
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 | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-20 |
Decision Date | 1994-10-28 |