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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph, ambulatory (without analysis)
510(k) Number K161062
Device Name NR Recorder
Norav Medical GmbH
Otto von Guericke Ring 10
Wiesbaden,  DE 65205
Applicant Contact David Seal
Licensale Inc
57 Lazy Brook Rd
Monroe,  CT  06468
Correspondent Contact Raymond Kelly
Regulation Number870.2800
Classification Product Code
Date Received04/15/2016
Decision Date 06/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No