510(k) K941995

NCE REPLACEMENT BATTERIES by National Custom Ent., Inc. — Product Code LDD

Clearance Details

Decision
ST ()
Decision Date
July 26, 1994
Date Received
April 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type