FDA 510(k) Application Details - K840935

Device Classification Name Ventilator, Emergency, Manual (Resuscitator)

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510(K) Number K840935
Device Name Ventilator, Emergency, Manual (Resuscitator)
Applicant INSPIRON CORP.

, US
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Regulation Number 868.5915

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Classification Product Code BTM
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Date Received 03/05/1984
Decision Date 04/05/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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