510(k) K961582

EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 by North American Technical Services Corp. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1996
Date Received
April 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type