FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGITAL RETINOSCOPIC PHOTOMETER
K Number: K951179
·
Decision May 30, 1995
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
1
Review Days
75
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Basic Information
- Device Name
- DIGITAL RETINOSCOPIC PHOTOMETER
- K Number
- K951179
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kudi Kalu, Inc.
- Date Received
- March 16, 1995
- Decision Date
- May 30, 1995
- Product Code
- HKO
- 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 |
|---|---|---|---|
| HKO | Refractometer, Ophthalmic | FDA class 1 | Ophthalmic |
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