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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
AlertWatch, Inc.
1600 Huron Parkway, Bldg. 520, Ste. 2326
Ann Arbor,  MI  48109
Applicant Contact Justin Adams
Biologics Consulting Group, Inc.
1555 King Street
Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number884.2740
Classification Product Code
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