510(k) K990125

HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K by Hewlett-Packard GmbH — Product Code DSI

K990125 is an FDA 510(k) premarket notification submitted by Hewlett-Packard GmbH for the device "HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code DSI (Detector And Alarm, Arrhythmia), 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
January 29, 1999
Date Received
January 13, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type