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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K123921
Device Name BODYTRONIC 200
Applicant
Bauerfeind AG
Triebeser Strasse 16
Zeulenroda-Triebes,  DE 07937
Applicant Contact INES EXNER
Correspondent
Bauerfeind AG
Triebeser Strasse 16
Zeulenroda-Triebes,  DE 07937
Correspondent Contact INES EXNER
Regulation Number870.2780
Classification Product Code
JOM  
Date Received12/20/2012
Decision Date 04/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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