Monitor, Eye Movement, Diagnostic
The Diagnostic Eye Movement Monitor is an ophthalmic device used to record and analyze eye movements for diagnostic purposes, including evaluation of saccadic function, smooth pursuit, nystagmus characterization, and vestibulo-ocular reflex assessment in neurological and ophthalmological conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence before marketing. The product code is HMC, regulated under 21 CFR 886.1510, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
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Basic Information
- Product Code
- HMC
- Device Class
- FDA class 2
- Regulation Number
- 886.1510
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931678 | ORTHOMET LHMC FEMORAL STEM | Oct 14, 1994 | Substantially Equivalent | Orthomet, Inc. |