The following data is part of a premarket notification filed by Levo Ag with the FDA for Levo C3.
| Device ID | K083017 |
| 510k Number | K083017 |
| Device Name: | LEVO C3 |
| Classification | Wheelchair, Standup |
| Applicant | LEVO AG ANGLIKERSTRASSE 20 5610 Wohlen, CH Ch-5610 |
| Contact | Thomas Raber |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-09 |
| Decision Date | 2008-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613045071503 | K083017 | 000 |