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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name recorder, magnetic tape, medical
510(k) Number K171936
Device Name Peerbridge Cor(TM) System
Applicant
Peerbridge Health INc.
1440 Broadway, 23rd Floor
New York,  NY  10018
Applicant Contact Arthur A. Bertolero
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/28/2017
Decision Date 09/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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