510(k) K874238
K874238 is an FDA 510(k) premarket notification submitted by Belmont Equipment Corp. for the device "MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY". The FDA issued a decision of Substantially Equivalent on December 7, 1987. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Belmont Equipment Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1987
- Date Received
- October 15, 1987
- 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