The following data is part of a premarket notification filed by Sota Precision Optics, Inc. with the FDA for Claris I310d Intraoral Camera System & Accessories.
Device ID | K061175 |
510k Number | K061175 |
Device Name: | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES |
Classification | Unit, Operative Dental |
Applicant | SOTA PRECISION OPTICS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
Contact | Jay Mansour |
Correspondent | Jay Mansour SOTA PRECISION OPTICS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-27 |
Decision Date | 2006-05-23 |
Summary: | summary |