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 |