FDA 510(k) Application Details - K160862

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K160862
Device Name System,Network And Communication,Physiological Monitors
Applicant AirStrip Technologies, Inc.
335 E. Sonterra Blvd, Suite 200
San Antonio, TX 78258 US
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Contact Andy Miller
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 03/29/2016
Decision Date 09/19/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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