FDA 510(k) Application Details - K963025

Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)

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510(K) Number K963025
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant SLEEPNET CORPORATION
1050 PERIMETER RD.,
LOCKHEED AIR CENTER
MANCHESTER, NH 03103 US
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Contact THOMAS E ASACKER
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 08/05/1996
Decision Date 11/01/1996
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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