FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Tono Vue Non-Contact Tonometer
K Number: K180820
·
Decision Dec 14, 2018
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
3
Review Days
260
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
- Tono Vue Non-Contact Tonometer
- K Number
- K180820
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crystalvue Medical Corporation
- Date Received
- March 29, 2018
- Decision Date
- December 14, 2018
- Product Code
- HKX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKX), ordered by most recent decision date.
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
FDA 510(k)
FDA Class 2
·Ophthalmic
VS Tabletop Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic
Intraocular Pressure Tonometer EASYTON
FDA 510(k)
FDA Class 2
·Ophthalmic
MiiS Horus Scope DPT 100
FDA 510(k)
FDA Class 2
·Ophthalmic
Keeler TonoCare Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic
VX130 Ophthalmic Diagnostic Device
FDA 510(k)
FDA Class 2
·Ophthalmic