ERGOSELECT/GE


Device Classification Name

exerciser, measuring

510(k) Number K112121
Device Name ERGOSELECT/GE
Applicant
ERGOLINE GMBH
schwarzwaldstrasse 5
tuttlingen, 

DE

78532

Applicant Contact andrea pecsi
Correspondent
ERGOLINE GMBH
schwarzwaldstrasse 5
tuttlingen, 

DE

78532

Correspodent Contact andrea pecsi
Regulation Number 890.5360
Classification Product Code
ISD  
Date Received 07/25/2011
Decision Date 10/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No