FDA 510(k) Application Details - K873472

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

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510(K) Number K873472
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant RESPIRATORY SUPPORT PRODUCTS, INC.
3183-D AIRWAY AVE.
COSTA MESA, CA US
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Contact ANTHONY V BERAN
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 08/28/1987
Decision Date 01/19/1988
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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