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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K954140
Device Name MASTERSCREEN IOS
Applicant
ERICH JAEGER GMBH & CO. KG
HOCHBERG D-97204
POSTFACH/P.O. BOX 5846
WURZBURG D-97008,  DE
Applicant Contact DETLEF GROTHEER
Correspondent
ERICH JAEGER GMBH & CO. KG
HOCHBERG D-97204
POSTFACH/P.O. BOX 5846
WURZBURG D-97008,  DE
Correspondent Contact DETLEF GROTHEER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/01/1995
Decision Date 12/14/1995
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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