FDA 510(k) Application Details - K952267

Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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510(K) Number K952267
Device Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Applicant NOVA-VENTRX
1974 RAYMOND DR.
NORTHBROOK, IL 60062 US
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Contact BERNARD R PALUCH
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Regulation Number 868.5270

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Classification Product Code BZE
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Date Received 05/15/1995
Decision Date 12/02/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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