510(k) K042260
K042260 is an FDA 510(k) premarket notification submitted by Takara Belmont USA, Inc. for the device "PHOT-X II, MODEL 303". The FDA issued a decision of Substantially Equivalent on September 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. Takara Belmont USA, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2004
- Date Received
- August 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type