510(k) K181887
K181887 is an FDA 510(k) premarket notification submitted by Advanced Medical Design Co., Ltd. for the device "AMD Anti-Fog Solution". The FDA issued a decision of Substantially Equivalent on January 22, 2019. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Advanced Medical Design Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2019
- Date Received
- July 13, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti Fog Solution And Accessories, Endoscopy
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.