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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K800935
Device Name R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)
Applicant
R2 Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
R2 Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/21/1980
Decision Date 05/23/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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