The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Models M1400a, M1402a & M1401a.
Device ID | K911139 |
510k Number | K911139 |
Device Name: | HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Contact | Richard Beebe |
Correspondent | Richard Beebe HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham, MA 02254 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-14 |
Decision Date | 1991-06-11 |