FDA 510(k) Application Details - K984295

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

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510(K) Number K984295
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA, OH 44036 US
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Contact EDWARD A KROLL
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Regulation Number 868.1720

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Classification Product Code CCL
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Date Received 12/01/1998
Decision Date 07/09/1999
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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