The following data is part of a premarket notification filed by Novavision, Inc. with the FDA for Novavision, Model 2.0.
| Device ID | K023623 |
| 510k Number | K023623 |
| Device Name: | NOVAVISION, MODEL 2.0 |
| Classification | Recorder, Attention Task Performance |
| Applicant | NOVAVISION, INC. 1111 PENNSYLVANIA AVE N.W. Washington, DC 20004 |
| Contact | Sandra J.p. Dennis |
| Correspondent | Sandra J.p. Dennis NOVAVISION, INC. 1111 PENNSYLVANIA AVE N.W. Washington, DC 20004 |
| Product Code | LQD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2003-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010599709 | K023623 | 000 |