510(k) K080884

QHRV 1 - HEALTH ASSESSMENT SYSTEM by Medtechs, LLC — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2008
Date Received
March 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type