FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AMD Anti-Fog Solution
K Number: K181887
·
Decision Jan 22, 2019
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
26
Applicant Total
2
Review Days
193
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AMD Anti-Fog Solution
- K Number
- K181887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Medical Design Co., Ltd.
- Date Received
- July 13, 2018
- Decision Date
- January 22, 2019
- Product Code
- OCT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCT | Anti Fog Solution And Accessories, Endoscopy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCT), ordered by most recent decision date.
KnoxFog Anti-fogging Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GOLFF Sterile Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E-Brik Visualization Assistant
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Konix Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VitreOx Anti-fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medline Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Advanced Medical Design Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K210248 | Lab Bag with Fabric Pouch | Jul 30, 2021 | Substantially Equivalent |