FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
K Number: K864037
·
Decision Nov 13, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
4
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
- K Number
- K864037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1450
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Kera Corp.
- Date Received
- October 16, 1986
- Decision Date
- November 13, 1986
- Product Code
- HJB
- 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 |
|---|---|---|---|
| HJB | Instrument, Measuring, Corneal Radius | FDA class 1 | Ophthalmic |
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