The following data is part of a premarket notification filed by Precise Optics Photo Medic Equipment, Inc. with the FDA for P1310 Automatic Brightness Stabilizer (abs).
| Device ID | K915405 |
| 510k Number | K915405 |
| Device Name: | P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PRECISE OPTICS PHOTO MEDIC EQUIPMENT, INC. 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Contact | Ron Hannington |
| Correspondent | Ron Hannington PRECISE OPTICS PHOTO MEDIC EQUIPMENT, INC. 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-02-04 |