510(k) K032341
K032341 is an FDA 510(k) premarket notification submitted by Sota Precision Optics, Inc. for the device "INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310". The FDA issued a decision of Substantially Equivalent on Aug 25, 2003. 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
- Aug 25, 2003
- Date Received
- Jul 29, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k)