FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K Number: K912581
·
Decision Dec 23, 1991
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
86
Applicant Total
44
Review Days
194
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Basic Information
- Device Name
- ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
- K Number
- K912581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carl Zeiss, Inc.
- Date Received
- June 12, 1991
- Decision Date
- December 23, 1991
- Product Code
- HLI
- 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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | FDA class 2 | Ophthalmic |
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