The following data is part of a premarket notification filed by Soderberg, Inc. with the FDA for Shin Nippon Auto Refractometer Qr-007n.
| Device ID | K901583 |
| 510k Number | K901583 |
| Device Name: | SHIN NIPPON AUTO REFRACTOMETER QR-007N |
| Classification | Refractometer, Ophthalmic |
| Applicant | SODERBERG, INC. 230 EVA ST. St. Paul, MN 55107 |
| Contact | Gordon H Oie |
| Correspondent | Gordon H Oie SODERBERG, INC. 230 EVA ST. St. Paul, MN 55107 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-04 |
| Decision Date | 1990-06-22 |