510(k) K895647

5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER by Advanced Technology Laboratories, Inc. — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1989
Date Received
September 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type