FDA 510(k) Application Details - K800905

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K800905
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant SIEMENS ELEMA AB

, US
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 04/21/1980
Decision Date 05/08/1980
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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