The following data is part of a premarket notification filed by Sota Precision Optics, Inc. with the FDA for Intra Oral Camera System And Accessories, Model Claris I310.
| Device ID | K032341 |
| 510k Number | K032341 |
| Device Name: | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 |
| Classification | Unit, Operative Dental |
| Applicant | SOTA PRECISION OPTICS, INC. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Donald J Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-29 |
| Decision Date | 2003-08-25 |
| Summary: | summary |