510(k) K992636

HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A by Hewlett-Packard Co. — Product Code DXJ

K992636 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A". The FDA issued a decision of Substantially Equivalent on August 31, 1999. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1999
Date Received
August 6, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type