FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTO-FIELD II OPHTHALMIC FIELD SCANNER
K Number: K781462
·
Decision Sep 14, 1978
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
40
Applicant Total
32
Review Days
20
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Basic Information
- Device Name
- AUTO-FIELD II OPHTHALMIC FIELD SCANNER
- K Number
- K781462
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Cavitron Corp.
- Date Received
- August 25, 1978
- Decision Date
- September 14, 1978
- Product Code
- HPT
- 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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | FDA class 1 | Ophthalmic |
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|---|---|---|---|
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| K802928 | SPIROMETRIC COMPUTER #SC-10 | Dec 17, 1980 | Substantially Equivalent |
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| K801877 | SLIT LAMP ATTACHMENT | Sep 16, 1980 | Substantially Equivalent |
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| K800722 | AUTO-FIELD D AUTOMATED VISUAL DETECTOR | Apr 29, 1980 | Substantially Equivalent |
| K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | Sep 19, 1979 | Substantially Equivalent |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Aug 22, 1979 | Substantially Equivalent |
| K782054 | LASER, CO2 SURGICAL | Jan 17, 1979 | Substantially Equivalent |