The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Acuracy 071, Dental, Intraoral-x-ray.
Device ID | K832065 |
510k Number | K832065 |
Device Name: | ACURACY 071, DENTAL, INTRAORAL-X-RAY |
Classification | Unit, X-ray, Intraoral |
Applicant | BELMONT EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAP |
CFR Regulation Number | 872.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-27 |
Decision Date | 1983-09-12 |