510(k) K791959

POST EXTRA SYSTOLIC POSTENTLATOR by Medrad, Inc. — Product Code IXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1980
Date Received
October 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Synchronizer, Ecg / Respirator, Radiographic
Device Class
Class I
Regulation Number
892.1970
Review Panel
RA
Submission Type