K943204 is an FDA 510(k) clearance for the VISTACAM. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on March 16, 1995, 254 days after receiving the submission on July 5, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K943204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1994 |
| Decision Date | March 16, 1995 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |