FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OBJECTIVE REFRACTOR
K Number: K802029
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
74
Registration Numbers
75
Same Product Code
34
Applicant Total
9
Review Days
83
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Basic Information
- Device Name
- OBJECTIVE REFRACTOR
- K Number
- K802029
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1760
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Zeiss Humphrey System
- Date Received
- August 21, 1980
- Decision Date
- November 12, 1980
- 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 Zeiss Humphrey System
| K Number | Device Name | ||
|---|---|---|---|
| K942439 | ZEISS OPMILAS 144 SURGICAL LASERS | Jul 1, 1994 | Substantially Equivalent |
| K923211 | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE | Nov 8, 1993 | Substantially Equivalent |
| K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED | Dec 10, 1992 | Substantially Equivalent |
| K852639 | HUMPHREY FIELD ANALYZER MODEL 630 | Sep 18, 1985 | Substantially Equivalent |
| K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 | Aug 12, 1985 | Substantially Equivalent |
| K821940 | THE HUMPHREY FIELD ANALYZER MODEL 610 | Jul 28, 1982 | Substantially Equivalent |
| K781994 | AUTOKERATOMETER, INSTRUMENT | Feb 12, 1979 | Substantially Equivalent |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Jan 26, 1979 | Substantially Equivalent |