The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Model 2001 Cp, Photon I, Dental, Intraoral X-ray.
| Device ID | K874238 |
| 510k Number | K874238 |
| Device Name: | MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
| Contact | John M Gardella |
| Correspondent | John M Gardella BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-15 |
| Decision Date | 1987-12-07 |