510(k) K970796

3M RED DOT 2560 & 2570 MONITORING ELECTRODES by 3M Healthcare — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1997
Date Received
March 4, 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