60 Fundus Camera CF-60UV
FDA 510(k) K946058 · Canon USA, Inc.
510(k) numberK946058
Submission
- Device name
- 60 Fundus Camera CF-60UV
- Applicant
- Canon USA, Inc.
Lake Success, NY, US - Received
- November 8, 1994
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 60 Fundus Camera CF-60UV cleared by the FDA?
60 Fundus Camera CF-60UV (K946058) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 87 days after the submission was received.
What is the product code of K946058?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.