FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTO REF-KERATOMETER, RK-3
K Number: K942242
·
Decision Sep 2, 1994
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
2
Review Days
116
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Basic Information
- Device Name
- AUTO REF-KERATOMETER, RK-3
- K Number
- K942242
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cannon U.S.A., Inc.
- Date Received
- May 9, 1994
- Decision Date
- September 2, 1994
- 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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Other Clearances by Cannon U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960839 | FILM SCANNER 300 | Dec 18, 1996 | Substantially Equivalent |