510(k) K123921

BODYTRONIC 200 by Bauerfeind AG — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2013
Date Received
December 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type