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FDA 510(k) Application Details - K140424
Device Classification Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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510(K) Number
K140424
Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE, PA 15146 US
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Contact
ALEXANDER L FRIEDMAN
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Regulation Number
868.5270
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Classification Product Code
BZE
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More FDA Info for this Product Code
Date Received
02/19/2014
Decision Date
11/14/2014
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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