Binocular Indirect Ophthalmoscope
FDA 510(k) K843304 · Mentor O & O, Inc.
510(k) numberK843304
Submission
- Device name
- Binocular Indirect Ophthalmoscope
- Applicant
- Mentor O & O, Inc.
Hingham, MA, US - Received
- August 23, 1984
- Decision date
- November 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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| K955245 | Mentor Meridian Phacoemulsification SystemHQC · Traditional | 02/12/1996SE |
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| K912904 | Mentor Odyssey Phacoemulsification SystemHQC · Traditional | 06/11/1992SE |
| K915340 | Mentor Horizon Low Vision MagnifierHJG · Traditional | 03/30/1992SE |
| K910637 | Mentor(R) Sur-E-Trol(R)FRN · Traditional | 05/13/1991SE |
| K911160 | Mentor(R) Wet-Field(R) II Ac Coagulator, 22-1305GEI · Traditional | 05/02/1991SE |
| K903878 | Mentor(R) Durastat(Tm) Autoclav Bipolar HemostatHQQ · Traditional | 11/05/1990SE |
| K895010 | Mentor Spectacle Binocular Indirect OphthalmoscopeHLI · Traditional | 09/11/1989SE |
| K890622 | Surg-E-Trol System I and System IIHQE · Traditional | 05/04/1989SE |
| K890595 | Mentor Anterior Segment VitrectorHKP · Traditional | 04/17/1989SE |
Questions and answers
When was Binocular Indirect Ophthalmoscope cleared by the FDA?
Binocular Indirect Ophthalmoscope (K843304) received a 510(k) decision of Substantially Equivalent on November 21, 1984, 90 days after the submission was received.
What is the product code of K843304?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.