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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Interpretor (Diagnostic)
510(k) Number K853190
Device Name SUPERSPIRO
Applicant
Cdx Corp.
10691 E. Bethany Dr. #900
Aurora,  CO  80014
Applicant Contact DAVID E LYNN
Correspondent
Cdx Corp.
10691 E. Bethany Dr. #900
Aurora,  CO  80014
Correspondent Contact DAVID E LYNN
Regulation Number868.1900
Classification Product Code
BZM  
Date Received07/30/1985
Decision Date 09/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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