FDA 510(k) Application Details - K211949

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K211949
Device Name System,Network And Communication,Physiological Monitors
Applicant AirStrip Technologies, Inc.
2915 West Bitters Road, Suite 215
San Antonio, TX 78248 US
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Contact JF Lancelot
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 06/23/2021
Decision Date 12/09/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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