The following data is part of a premarket notification filed by S.a. Instrumentation Difra with the FDA for Eyetracker/ideas.
| Device ID | K070670 |
| 510k Number | K070670 |
| Device Name: | EYETRACKER/IDEAS |
| Classification | Nystagmograph |
| Applicant | S.A. INSTRUMENTATION DIFRA 205 CO. RD. 128A SUITE 200 Cheyenne, WY 82007 -1831 |
| Contact | Guido Pagnacco |
| Correspondent | Guido Pagnacco S.A. INSTRUMENTATION DIFRA 205 CO. RD. 128A SUITE 200 Cheyenne, WY 82007 -1831 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B516222210 | K070670 | 000 |
| B516221350 | K070670 | 000 |
| B516221340 | K070670 | 000 |
| B516221280 | K070670 | 000 |
| B516223150 | K070670 | 000 |
| B516311790 | K070670 | 000 |
| B516320980 | K070670 | 000 |