Stand, Instrument, Ophthalmic, Non-Powered
The Non-Powered Ophthalmic Instrument Stand is a manual support stand designed to hold and position ophthalmic examination instruments during clinical use, providing a stable mounting platform in examination rooms. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without any premarket submission. The product code is HMG, regulated under 21 CFR 886.1860, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HMG
- Device Class
- FDA class 1
- Regulation Number
- 886.1860
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900161 | A-SCAN ROLL-AROUND STAND | Feb 16, 1990 | Substantially Equivalent | Jedmed Instrument Co. |
| K883575 | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE | Sep 12, 1988 | Substantially Equivalent | Site Microsurgical Systems, Inc. |
| K873554 | GORSK INSTRUMENT REST | Oct 23, 1987 | Substantially Equivalent | Gorsk, Inc. |
| K841759 | OPHTHALMIC TABLE | Jun 01, 1984 | Substantially Equivalent | Woodlyn, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.