The following data is part of a premarket notification filed by Precise Optics with the FDA for Precision Optics Image Coupler.
| Device ID | K903458 |
| 510k Number | K903458 |
| Device Name: | PRECISION OPTICS IMAGE COUPLER |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Contact | Francis L Pugsley |
| Correspondent | Francis L Pugsley PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-01 |
| Decision Date | 1990-10-19 |