The following data is part of a premarket notification filed by Golden Vision, Inc. with the FDA for Goldman Manual Tonometer.
| Device ID | K981432 |
| 510k Number | K981432 |
| Device Name: | GOLDMAN MANUAL TONOMETER |
| Classification | Tonometer, Manual |
| Applicant | GOLDEN VISION, INC. 7436 S.W. 117TH AVE.,SUITE 103 Miami, FL 33183 -3816 |
| Contact | Andres R Quiroz |
| Correspondent | Andres R Quiroz GOLDEN VISION, INC. 7436 S.W. 117TH AVE.,SUITE 103 Miami, FL 33183 -3816 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1999-01-12 |