FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K Number: K970029
·
Decision Apr 2, 1997
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
46
Applicant Total
60
Review Days
89
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Basic Information
- Device Name
- KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
- K Number
- K970029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Keeler Instruments, Inc.
- Date Received
- January 3, 1997
- Decision Date
- April 2, 1997
- Product Code
- HLJ
- 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 |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | FDA class 2 | Ophthalmic |
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