FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KEELER/KONAN SPECULAR MICROSCOPE
K Number: K810403
·
Decision May 13, 1981
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
5
Review Days
84
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Basic Information
- Device Name
- KEELER/KONAN SPECULAR MICROSCOPE
- K Number
- K810403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Optical Products , Ltd.
- Date Received
- February 18, 1981
- Decision Date
- May 13, 1981
- 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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Other Clearances by Keeler Optical Products , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Jul 21, 1980 | Substantially Equivalent |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Dec 11, 1979 | Substantially Equivalent |
| K782141 | LEVIGATOR, KEELER PHOKO | Jan 26, 1979 | Substantially Equivalent |
| K781892 | LOCATOR, FOREIGN BODY | Dec 4, 1978 | Substantially Equivalent |