Amer. Medical Optics Monocular Indirect Ophthalmas
FDA 510(k) K851264 · American Medical Optics
510(k) numberK851264
Submission
- Device name
- Amer. Medical Optics Monocular Indirect Ophthalmas
- Applicant
- American Medical Optics
Irvine, CA, US - Received
- March 28, 1985
- Decision date
- May 1, 1985
- 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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More from Bioptigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860001 | Barraquer-Krumeich Refractive SetHNO · Traditional | 02/04/1986SE |
| K851263 | Amer. Medical Optic Monocular Direct OphthalmascopHLI · Traditional | 05/01/1985SE |
| K851262 | Amer. Medical Optical Binocular Indirect OphthalmaHLI · Traditional | 04/30/1985SE |
| K844150 | Medical Optics Phacoemulsification KitHQC · Traditional | 12/11/1984SE |
| K843966 | Argon/Krypton Laser Photocoagulator SysHQB · Traditional | 11/08/1984SE |
| K843965 | Argon Laser Photocoagulator SysHQF · Traditional | 11/06/1984SE |
| K842504 | Amer. Medical Optics Digital Kerato-HQL · Traditional | 10/01/1984SE |
| K842197 | American Medical Optics I/A Kit- IrrigHQE · Traditional | 10/01/1984SE |
| K842127 | American Medical Optics Imaging SysIYO · Traditional | 09/07/1984SE |
| K842251 | Ameri. Medical Optics Argon Laser PhotoHQF · Traditional | 08/15/1984SE |
Questions and answers
When was Amer. Medical Optics Monocular Indirect Ophthalmas cleared by the FDA?
Amer. Medical Optics Monocular Indirect Ophthalmas (K851264) received a 510(k) decision of Substantially Equivalent on May 1, 1985, 34 days after the submission was received.
What is the product code of K851264?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.