FDA 510(k) Application Details - K000396

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K000396
Device Name Ventilatory Effort Recorder
Applicant ERICH JAEGER, INC.
22705 SAVI RANCH PKWY.
YORBA LINDA, CA 92887-4645 US
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Contact LARRY MURDOCK
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 02/07/2000
Decision Date 12/27/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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