Auto-Field II Ophthalmic Field Scanner
FDA 510(k) K781462 · Cavitron Corp.
510(k) numberK781462
Submission
- Device name
- Auto-Field II Ophthalmic Field Scanner
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- August 25, 1978
- Decision date
- September 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPT – Perimeter, Automatic, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
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| K023623 | Novavision, Model 2.0HPT · Traditional | Novavision, Inc. | 04/22/2003SE |
| K971156 | Kasha Visual Field SystemHPT · Traditional | Kasha Software, Inc. | 05/28/1997SE |
| K961090 | Automatic Visual Field Plotter AP-125HPT · Traditional | Kowa Optimed, Inc. | 06/17/1996SE |
| K954167 | Humphrey Field Analyzer (Hfa II)HPT · Traditional | Carl Zeiss, Inc. | 11/24/1995SE |
| K954037 | Field TrendHPT · Traditional | Synemed, Inc. | 11/17/1995SE |
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| K801623 | Cavitron Ultrasonic Surg. Aspir. CusaLFL · Traditional | 11/18/1980SE |
| K801877 | Slit Lamp AttachmentHQB · Traditional | 09/16/1980SE |
| K800869 | Model PM-20(N)(R)CO2 Patient Monitor/AlaCCK · Traditional | 05/28/1980SE |
| K800722 | Auto-Field D Automated Visual DetectorHPT · Traditional | 04/29/1980SE |
| K791585 | Model G-61 Ultrasonic Dental UnitELC · Traditional | 09/19/1979SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | 08/22/1979SE |
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Questions and answers
When was Auto-Field II Ophthalmic Field Scanner cleared by the FDA?
Auto-Field II Ophthalmic Field Scanner (K781462) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 20 days after the submission was received.
What is the product code of K781462?
The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.