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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 K884775
Device Name ARBO PINK H82P
Applicant
ARBO MEDICAL, INC.
35 DANBURY ROAD, SUITE 2
wilton,  CT  06897
Applicant Contact wayne d shockloss
Correspondent
ARBO MEDICAL, INC.
35 DANBURY ROAD, SUITE 2
wilton,  CT  06897
Correspondent Contact wayne d shockloss
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/16/1988
Decision Date 02/06/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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