FDA 510(k) Application Details - K050309

Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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510(K) Number K050309
Device Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant VIASYS MEDSYSTEMS
100 CHADDICK DR.
WHEELING, IL 60090 US
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Contact STEPHANIE WASIELEWSKI
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Regulation Number 868.2600

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Classification Product Code CAP
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Date Received 02/08/2005
Decision Date 03/25/2005
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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