FDA 510(k) Application Details - K990199

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K990199
Device Name Ventilatory Effort Recorder
Applicant RESPIRONICS, INC.
1501 ARDMORE BLVD.
PITTSBURGH, PA 15221-4401 US
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Contact BETSY CORTELLONI
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 01/21/1999
Decision Date 04/19/1999
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 N
Expedited Review



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