FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KARICKHOFF KERATOSCOPE
K Number: K830008
·
Decision Jan 26, 1983
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
4
Review Days
23
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Basic Information
- Device Name
- KARICKHOFF KERATOSCOPE
- K Number
- K830008
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgidev Corp.
- Date Received
- January 3, 1983
- Decision Date
- January 26, 1983
- Product Code
- HLR
- 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 |
|---|---|---|---|
| HLR | Keratoscope, Battery-Powered | FDA class 1 | Ophthalmic |
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