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FDA 510(k)

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

K-Number: K041546 · 2004-06-23

ApplicantCanon, Inc.
Decision Date2004-06-23
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2004-06-23 under 510(k) number K041546. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL FUNDUS CAMERA, MODEL CF-60DSI?

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI is a medical device that received FDA 510(k) clearance on 2004-06-23. The listed applicant is Canon, Inc.. The 510(k) number is K041546.

When did DIGITAL FUNDUS CAMERA, MODEL CF-60DSI receive FDA 510(k) clearance?

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI received FDA 510(k) clearance on 2004-06-23, under 510(k) number K041546.

Who is the listed applicant for DIGITAL FUNDUS CAMERA, MODEL CF-60DSI?

The FDA 510(k) record lists Canon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL FUNDUS CAMERA, MODEL CF-60DSI?

The FDA product code for DIGITAL FUNDUS CAMERA, MODEL CF-60DSI is HKI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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