FDA 510(k) Application Details - K881184

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

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510(K) Number K881184
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK, NJ US
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Contact RONALD GUIDO
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 03/21/1988
Decision Date 05/25/1988
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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