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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
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact LARRY MURDOCK
Correspondent
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
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
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