FDA 510(k) Application Details - K040069

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K040069
Device Name Ventilatory Effort Recorder
Applicant DYMEDIX, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 01/14/2004
Decision Date 05/05/2004
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 Y
Expedited Review



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