The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Carevue 9000 Clinical Information System, Model M2331a.
Device ID | K992636 |
510k Number | K992636 |
Device Name: | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Contact | Mike Hudon |
Correspondent | Mike Hudon HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-06 |
Decision Date | 1999-08-31 |
Summary: | summary |