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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 K211949
Device Name AirStrip ONE Web Client with Alarm Communication Management (ACM)
Applicant
Airstrip Technologies, Inc.
2915 W. Bitters Rd., Suite 215
San Antonio,  TX  78248
Applicant Contact JF Lancelot
Correspondent
Airstrip Technologies, Inc.
2915 W. Bitters Rd., Suite 215
San Antonio,  TX  78248
Correspondent Contact JF Lancelot
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/23/2021
Decision Date 12/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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