FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K Number: K925641
·
Decision Sep 9, 1993
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
44
Review Days
304
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Basic Information
- Device Name
- ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
- K Number
- K925641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carl Zeiss, Inc.
- Date Received
- November 9, 1992
- Decision Date
- September 9, 1993
- 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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