Anomaloscope
The Anomaloscope is a specialized ophthalmic instrument used to diagnose and classify color vision deficiencies by requiring the patient to match a yellow color by adjusting a mixture of red and green light. It is classified as FDA Class 1, representing the lowest risk level, subject only to general controls without a premarket submission requirement. The product code is HIW, regulated under 21 CFR 886.1070, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HIW
- Device Class
- FDA class 1
- Regulation Number
- 886.1070
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930575 | KAMPPETER ANOMALOSCOPE | Feb 25, 1994 | Substantially Equivalent | Bova Intl. |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Oct 23, 1991 | Substantially Equivalent | Lkc Technologies, Inc. |
| K860174 | GUNKEL CHROMAGRAPH COLOR VISION TESTER | Apr 04, 1986 | Substantially Equivalent | Chromagraphics, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.