FDA 510(k) Application Details - K140264

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K140264
Device Name Gas-Machine, Anesthesia
Applicant THORNHILL RESEARCH INC.
210 Dundas St. West
Suite 200
TORONTO, ONTARIO M5G 2E8 CA
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Contact CLIFF ANSEL
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 02/03/2014
Decision Date 01/05/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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