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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K192952
Device Name Spire Health Remote Patient Monitoring System
Applicant
Spire, Inc. D/B/A Spire Health
2030 Harrison St.
San Francisco,  CA  94110
Applicant Contact Joanne Hollenbach
Correspondent
Enzyme Corporation
360 Langton St., Suite 100
San Francisco,  CA  94103
Correspondent Contact Jared Seehafer
Regulation Number870.2300
Classification Product Code
MSX  
Date Received10/21/2019
Decision Date 06/05/2020
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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