FDA 510(k) Application Details - K071230

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K071230
Device Name Ventilatory Effort Recorder
Applicant ADVANCED BRAIN MONITORING, INC.
2237 FARADAY AVENUE
SUITE 100
CARLSBAD, CA 92008 US
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Contact DANIEL J LEVENDOWSKI
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 05/03/2007
Decision Date 10/03/2007
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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