510(k) K874238

MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY by Belmont Equipment Corp. — Product Code EHD

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