FDA 510(k) Application Details - K090958

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K090958
Device Name Ventilatory Effort Recorder
Applicant INO THERAPEUTICS LLC
2902 DAIRY DR.
MADISON, WI 53718 US
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Contact DAVID TRUEBLOOD
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 04/06/2009
Decision Date 06/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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