FDA 510(k) Application Details - K900569

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

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510(K) Number K900569
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant MERCED MEDICAL, INC.
113300 A-49TH ST. NORTH
CLEARWATER, FL US
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Contact JEFF RATNER
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Regulation Number 868.5450

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Classification Product Code BTT
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Date Received 02/07/1990
Decision Date 04/10/1990
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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