FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTEC 3000
K Number: K924741
·
Decision Apr 6, 1993
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
5
Review Days
196
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Basic Information
- Device Name
- OPTEC 3000
- K Number
- K924741
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stereo Optical Co., Inc.
- Date Received
- September 22, 1992
- Decision Date
- April 6, 1993
- 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 Stereo Optical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904828 | OPTEC 2300 AFVT, ARMED FORCES VISION TESTER | Jan 18, 1991 | Substantially Equivalent |
| K875237 | OPTEC 1000 DMV VISION TESTER MODIFY | Mar 17, 1988 | Substantially Equivalent |
| K863509 | OPTEC 1000 DMV | Nov 10, 1986 | Substantially Equivalent |
| K843042 | VISION TESTER | Oct 5, 1984 | Substantially Equivalent |