510(k) K024215

ENERTRON CPR JACK by Enertron Engineering Co. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2004
Date Received
December 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type