510(k) K905157

FLOSCOPE VASCULAR LAB. by Advance Medical Device, Inc. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1991
Date Received
November 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type