510(k) K974697

REUSABLE FINGER SENSOR 3444 by Bci Intl., Inc. — Product Code DQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
December 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cardiograph, Apex (Vibrocardiograph)
Device Class
Class II
Regulation Number
870.2310
Review Panel
CV
Submission Type