The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Model 78730 Carevue 5000.
Device ID | K922210 |
510k Number | K922210 |
Device Name: | HEWLETT-PACKARD MODEL 78730 CAREVUE 5000 |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Contact | William Kole |
Correspondent | William Kole HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-12 |
Decision Date | 1993-04-01 |