Canon Non-Mydriatic Retinal Camera CR3-45NM
FDA 510(k) K855170 · Canon USA, Inc.
510(k) numberK855170
Submission
- Device name
- Canon Non-Mydriatic Retinal Camera CR3-45NM
- Applicant
- Canon USA, Inc.
Jericho, NY, US - Received
- December 26, 1985
- Decision date
- February 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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Questions and answers
When was Canon Non-Mydriatic Retinal Camera CR3-45NM cleared by the FDA?
Canon Non-Mydriatic Retinal Camera CR3-45NM (K855170) received a 510(k) decision of Substantially Equivalent on February 27, 1986, 63 days after the submission was received.
What is the product code of K855170?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.