FDA 510(k) Application Details - K022642

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K022642
Device Name Ventilator, Non-Continuous (Respirator)
Applicant INVACARE CORP.
ONE INVACARE WAY
ELYRIA, OH 44036-2125 US
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Contact RAE ANN FARROW
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 08/08/2002
Decision Date 02/11/2003
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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