FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K Number: K893170
·
Decision Jun 5, 1989
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
11
Applicant Total
59
Review Days
41
Basic Information
- Device Name
- VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
- K Number
- K893170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1945
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- KEELER INSTRUMENTS, INC.
- Date Received
- April 25, 1989
- Decision Date
- June 5, 1989
- Product Code
- HJM
- 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 |
|---|---|---|---|
| HJM | Transilluminator, Ac-Powered | FDA class 2 | Ophthalmic |
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