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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 data
510(k) Number K023120
Device Name OXYCON MOBILE
Applicant
ERICH JAEGER GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact EARL DRAPER
Correspondent
ERICH JAEGER GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact EARL DRAPER
Regulation Number868.1880
Classification Product Code
BZC  
Date Received09/19/2002
Decision Date 11/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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