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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
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