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FDA 510(k) Application Details - K123921
Device Classification Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
More FDA Info for this Device
510(K) Number
K123921
Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant
BAUERFEIND AG
TRIEBESER STRASSE 16
ZEULENRODA-TRIEBES 07937 DE
Other 510(k) Applications for this Company
Contact
INES EXNER
Other 510(k) Applications for this Contact
Regulation Number
870.2780
More FDA Info for this Regulation Number
Classification Product Code
JOM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/20/2012
Decision Date
04/26/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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