The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Topcon Model Bv-1000 Automated Subjective Refraction System.
| Device ID | K031831 |
| 510k Number | K031831 |
| Device Name: | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM |
| Classification | Refractometer, Ophthalmic |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 37 WEST CENTURY RD. Paramus, NJ 07652 |
| Contact | Donald H Winfield |
| Correspondent | Donald H Winfield TOPCON MEDICAL SYSTEMS, INC. 37 WEST CENTURY RD. Paramus, NJ 07652 |
| Product Code | HKO |
| Subsequent Product Code | HKN |
| Subsequent Product Code | HOX |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-12-19 |
| Summary: | summary |