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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plethysmograph, volume
510(k) Number K951901
Device Name MASTERSCREEN PFT BODY
Applicant
ERICH JAEGER GMBH & CO. KG
LEIBNIZSTRASSE 7
HOECHBERG,  DE D-97204
Applicant Contact DETLEF GROTHEER
Correspondent
ERICH JAEGER GMBH & CO. KG
LEIBNIZSTRASSE 7
HOECHBERG,  DE D-97204
Correspondent Contact DETLEF GROTHEER
Regulation Number868.1760
Classification Product Code
JEH  
Date Received04/24/1995
Decision Date 07/31/1995
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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