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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K183370
Device Name PeraMobile and PeraWatch
Applicant
PeraHealth, Inc.
6302 Fairview Rd.,Suite 310
Charlotte,  NC  28210
Applicant Contact Brad Coleman
Correspondent
Biologics Consulting Group
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/04/2018
Decision Date 09/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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