FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Applanation Tonometer
K Number: K142263
·
Decision Apr 15, 2016
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
3
Review Days
610
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Basic Information
- Device Name
- Applanation Tonometer
- K Number
- K142263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shanghai Mediworks Precision Instruments Co. , Ltd.
- Date Received
- August 14, 2014
- Decision Date
- April 15, 2016
- Product Code
- HKY
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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