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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K981366
Device Name STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact LARRY MURDOCK
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact LARRY MURDOCK
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/15/1998
Decision Date 10/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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