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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, monitoring, perinatal
510(k) Number K173715
Device Name AlertWatch:OB
Applicant
AlertWatch, Inc.
1600 Huron Parkway, Bldg. 520, Ste. 2326
Ann Arbor,  MI  48109
Applicant Contact Justin Adams
Correspondent
Biologics Consulting Group, Inc.
1555 King Street
Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/04/2017
Decision Date 04/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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