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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K050309
Device Name PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
Applicant
Viasys Medsystems
100 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact STEPHANIE WASIELEWSKI
Correspondent
Viasys Medsystems
100 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact STEPHANIE WASIELEWSKI
Regulation Number868.2600
Classification Product Code
CAP  
Date Received02/08/2005
Decision Date 03/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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