510(k) K924516

OP3/VP4 by Huntleigh Technology, Inc. — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1993
Date Received
September 4, 1992
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