510(k) K061175
K061175 is an FDA 510(k) premarket notification submitted by Sota Precision Optics, Inc. for the device "CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 23, 2006. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Sota Precision Optics, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2006
- Date Received
- Apr 27, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k)