K023623 is an FDA 510(k) clearance for the NOVAVISION, MODEL 2.0. This device is classified as a Perimeter, Automatic, Ac-powered (Class I - General Controls, product code HPT).
Submitted by Novavision, Inc. (Washington, US). The FDA issued a Cleared decision on April 22, 2003, 175 days after receiving the submission on October 29, 2002.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 886.1605.
| 510(k) Number | K023623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2002 |
| Decision Date | April 22, 2003 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HPT — Perimeter, Automatic, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1605 |