The following data is part of a premarket notification filed by Kudi Kalu, Inc. with the FDA for Digital Retinoscopic Photometer.
| Device ID | K951179 |
| 510k Number | K951179 |
| Device Name: | DIGITAL RETINOSCOPIC PHOTOMETER |
| Classification | Refractometer, Ophthalmic |
| Applicant | KUDI KALU, INC. 310 CLINTON AVENUE WEST Huntsville, AL 35801 |
| Contact | S. H Hay |
| Correspondent | S. H Hay KUDI KALU, INC. 310 CLINTON AVENUE WEST Huntsville, AL 35801 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-16 |
| Decision Date | 1995-05-30 |