FDA 510(k) Application Details - K002284

Device Classification Name Conserver, Oxygen

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510(K) Number K002284
Device Name Conserver, Oxygen
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 868.5905

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Classification Product Code NFB
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Date Received 07/26/2000
Decision Date 10/24/2000
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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