510(k) K141293
K141293 is an FDA 510(k) premarket notification submitted by Takara Belmont Corporation for the device "PHOT-X IIS MODEL 505". The FDA issued a decision of Substantially Equivalent on Sep 3, 2014. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), 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
- Sep 3, 2014
- Date Received
- May 19, 2014
- Clearance Type
- Traditional
- 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
- 510(k)