FDA 510(k) Application Details - K072201

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K072201
Device Name Ventilatory Effort Recorder
Applicant COMPUMEDICS LIMITED
30-40 FLOCKHART STREET
ABBOTSFORD
MELBOURNE, VICTORIA 3067 AU
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Contact GORDON FERGUSON
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 08/08/2007
Decision Date 04/14/2008
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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