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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 K960078
Device Name ASTHMA MONITOR
Applicant
ERICH JAEGER, INC.
LEIBNIZSTRABE 7
D-97204
HOECHBERG, GERMANY,  DE
Applicant Contact D GROTHEER
Correspondent
ERICH JAEGER, INC.
LEIBNIZSTRABE 7
D-97204
HOECHBERG, GERMANY,  DE
Correspondent Contact D GROTHEER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/05/1996
Decision Date 09/20/1996
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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