The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Acuray 071a Dental Intraoral X-ray.
| Device ID | K834279 |
| 510k Number | K834279 |
| Device Name: | ACURAY 071A DENTAL INTRAORAL X-RAY |
| Classification | Unit, X-ray, Intraoral |
| Applicant | BELMONT EQUIPMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-22 |
| Decision Date | 1983-12-29 |