The following data is part of a premarket notification filed by Ergoline Gmbh with the FDA for Ergoselect/ge.
Device ID | K112121 |
510k Number | K112121 |
Device Name: | ERGOSELECT/GE |
Classification | Exerciser, Measuring |
Applicant | ERGOLINE GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, DE 78532 |
Contact | Andrea Pecsi |
Correspondent | Andrea Pecsi ERGOLINE GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, DE 78532 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-25 |
Decision Date | 2012-10-31 |
Summary: | summary |