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 |