The following data is part of a premarket notification filed by Precise Optics Photo Medic Equipment, Inc. with the FDA for P2900 X-ray Generator.
| Device ID | K921516 |
| 510k Number | K921516 |
| Device Name: | P2900 X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | PRECISE OPTICS PHOTO MEDIC EQUIPMENT, INC. 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Contact | Hannington |
| Correspondent | Hannington PRECISE OPTICS PHOTO MEDIC EQUIPMENT, INC. 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1992-05-28 |