FDA 510(k) Application Details - K893034

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

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510(K) Number K893034
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant BEAR MEDICAL SYSTEMS, INC.
2085 RUSTIN AVE.
RIVERSIDE, CA US
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Contact TONY WONDKA
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 04/20/1989
Decision Date 07/14/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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