FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
NON-CONTACT TONOMETER T-2
K Number: K943939
·
Decision May 12, 1995
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
43
Review Days
273
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
- NON-CONTACT TONOMETER T-2
- K Number
- K943939
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon, Inc.
- Date Received
- August 12, 1994
- Decision Date
- May 12, 1995
- 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
Tono Vue Non-Contact Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Canon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252503 | Intelligent NR | Apr 30, 2026 | Substantially Equivalent |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | May 15, 2024 | Substantially Equivalent |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Apr 26, 2024 | Substantially Equivalent |
| K230175 | Digital Radiography CXDI-CS01 | Feb 15, 2023 | Substantially Equivalent |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Oct 17, 2022 | Substantially Equivalent |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Sep 29, 2022 | Substantially Equivalent |
| K222661 | Digital Radiography CXDI-CS01 | Sep 27, 2022 | Substantially Equivalent |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Jul 15, 2022 | Substantially Equivalent |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Jun 14, 2022 | Substantially Equivalent |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Feb 4, 2022 | Substantially Equivalent |