The following data is part of a premarket notification filed by Ergoline Gmbh with the FDA for Ergoselect 100 K/p, Ergoselect 200 K/p.
| Device ID | K053078 |
| 510k Number | K053078 |
| Device Name: | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P |
| Classification | Exerciser, Measuring |
| Applicant | ERGOLINE GMBH LINDENSTR. 6 Bitz, B-w, DE 72475 |
| Contact | Haiko Bell |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2006-04-27 |
| Summary: | summary |