The following data is part of a premarket notification filed by Advanced Medical Design Co., Ltd with the FDA for Amd Anti-fog Solution.
| Device ID | K181887 |
| 510k Number | K181887 |
| Device Name: | AMD Anti-Fog Solution |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | Advanced Medical Design Co., Ltd 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City, TW 24888 |
| Contact | Silvia Yeh |
| Correspondent | Silvia Yeh Advanced Medical Design Co., Ltd 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City, TW 24888 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2019-01-22 |
| Summary: | summary |