510(k) K981376

HEWLETT-PACKARD M1205A VIRIDIA 24 CT by Hewlett-Packard Co. — Product Code DSI

K981376 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "HEWLETT-PACKARD M1205A VIRIDIA 24 CT". The FDA issued a decision of Substantially Equivalent on January 4, 1999. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1999
Date Received
April 16, 1998
Clearance Type
Traditional
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