510(k) K110160
K110160 is an FDA 510(k) premarket notification submitted by Takara Belmont Corporation for the device "BEL-CYPHER N". The FDA issued a decision of Substantially Equivalent on Feb 17, 2011. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Takara Belmont Corporation has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 17, 2011
- Date Received
- Jan 19, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)