510(k) K040556
K040556 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY". The FDA issued a decision of Substantially Equivalent on April 7, 2004. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2004
- Date Received
- March 2, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type