FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
K Number: K864467
·
Decision Dec 15, 1986
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
5
Applicant Total
60
Review Days
33
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Basic Information
- Device Name
- HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
- K Number
- K864467
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- November 12, 1986
- Decision Date
- December 15, 1986
- Product Code
- HOO
- 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 |
|---|---|---|---|
| HOO | Perimeter, Ac-Powered | FDA class 1 | Ophthalmic |
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