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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 K980094
Device Name MODIFICATION TO THE OXYCONALPHA
Applicant
ERICH JAEGER B.V.
REGULIERENING 11
NL-3981 LA BUNNIK,  NL NL-3981
Applicant Contact LEO D BAKKER
Correspondent
ERICH JAEGER B.V.
REGULIERENING 11
NL-3981 LA BUNNIK,  NL NL-3981
Correspondent Contact LEO D BAKKER
Regulation Number868.1890
Classification Product Code
BTY  
Date Received01/09/1998
Decision Date 07/28/1998
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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