510(k) K954847

DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES by Ocg Systems, Inc. — Product Code HFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1996
Date Received
October 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Uterine Contraction, External (For Use In Clinic)
Device Class
Class II
Regulation Number
884.2720
Review Panel
OB
Submission Type