Digital Fundus Camera, Model CF-60DSI
FDA 510(k) K041546 · Canon, Inc.
510(k) numberK041546
Submission
- Device name
- Digital Fundus Camera, Model CF-60DSI
- Applicant
- Canon, Inc.
Lake Success, NY, US - Received
- June 9, 2004
- Decision date
- June 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Digital Fundus Camera, Model CF-60DSI cleared by the FDA?
Digital Fundus Camera, Model CF-60DSI (K041546) received a 510(k) decision of Substantially Equivalent on June 23, 2004, 14 days after the submission was received.
What is the product code of K041546?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.