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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 K936108
Device Name MASTERSCREEN BODY
Applicant
Erich Jaeger GmbH & Co. KG
Postfach 5846, 8700 Wuerzburg
1
Wuerzburg, Germany,  DE
Applicant Contact V.D. GROTHER
Correspondent
Erich Jaeger GmbH & Co. KG
Postfach 5846, 8700 Wuerzburg
1
Wuerzburg, Germany,  DE
Correspondent Contact V.D. GROTHER
Regulation Number868.1760
Classification Product Code
JEH  
Date Received12/27/1993
Decision Date 02/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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