FDA 510(k) Application Details - K003939

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K003939
Device Name Generator, Oxygen, Portable
Applicant INVACARE CORP.
ONE INVACARE WAY
ELYRIA, OH 44036-2125 US
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Contact EDWARD A KROLL
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 12/21/2000
Decision Date 03/21/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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