510(k) K012298
K012298 is an FDA 510(k) premarket notification submitted by Cerium Optical Technologies, Inc. for the device "THE INTUITIVE COLORIMETER". The FDA issued a decision of Substantially Equivalent on September 26, 2001. The device falls under product code NFD (Selector, Color, Spectacle, Lens, Tint), a Class I device regulated under 21 CFR 886.1160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2001
- Date Received
- July 20, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Selector, Color, Spectacle, Lens, Tint
- Device Class
- Class I
- Regulation Number
- 886.1160
- Review Panel
- OP
- Submission Type