FDA 510(k) Application Details - K071556

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K071556
Device Name Ventilatory Effort Recorder
Applicant SOMNOMEDICS GMBH
719 A STREET NE
WASHINGTON, DC 20002 US
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Contact CHERITA JAMES
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 06/07/2007
Decision Date 07/18/2007
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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