510(k) K992674

HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A by Hewlett-Packard GmbH — Product Code MHX

K992674 is an FDA 510(k) premarket notification submitted by Hewlett-Packard GmbH for the device "HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A". The FDA issued a decision of Substantially Equivalent on November 8, 1999. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Hewlett-Packard GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1999
Date Received
August 10, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type