FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIWORKS SLIT LAMP
K Number: K100439
·
Decision Jul 16, 2010
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
3
Review Days
149
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Basic Information
- Device Name
- MEDIWORKS SLIT LAMP
- K Number
- K100439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shanghai Mediworks Precision Instruments Co. , Ltd.
- Date Received
- February 17, 2010
- Decision Date
- July 16, 2010
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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