FDA 510(k) Application Details - K990565

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K990565
Device Name Ventilatory Effort Recorder
Applicant NELLCOR PURITAN BENNETT, INC.
2800 NORTHWEST BLVD.
MINNEAPOLIS, MN 55441-2625 US
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Contact DARIN BUSCH
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 02/22/1999
Decision Date 08/18/1999
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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