The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Belray/model 096, Dental Intraoral X-ray.
| Device ID | K963699 |
| 510k Number | K963699 |
| Device Name: | BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | BELMONT EQUIPMENT CORP. 101 BELMONT DR. Somerset, NJ 08873 -1204 |
| Contact | John E Collins |
| Correspondent | John E Collins BELMONT EQUIPMENT CORP. 101 BELMONT DR. Somerset, NJ 08873 -1204 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-12-23 |