FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISTA STREAK RETINOSCOPE (AC-POWERED)
K Number: K893171
·
Decision Sep 21, 1989
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
5
Applicant Total
60
Review Days
149
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Basic Information
- Device Name
- VISTA STREAK RETINOSCOPE (AC-POWERED)
- K Number
- K893171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1780
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- April 25, 1989
- Decision Date
- September 21, 1989
- Product Code
- HKL
- 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 |
|---|---|---|---|
| HKL | Retinoscope, Ac-Powered | FDA class 2 | Ophthalmic |
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