510(k) K974445

3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 by 3M Healthcare — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1998
Date Received
November 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type