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FDA 510(k)

DIGITAL RETINAL CAMERA, CR-1 MARK II

K-Number: K090466 · 2009-03-23

ApplicantCanon, Inc.
Decision Date2009-03-23
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGITAL RETINAL CAMERA, CR-1 MARK II is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K090466. 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 RETINAL CAMERA, CR-1 MARK II?

DIGITAL RETINAL CAMERA, CR-1 MARK II is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Canon, Inc.. The 510(k) number is K090466.

When did DIGITAL RETINAL CAMERA, CR-1 MARK II receive FDA 510(k) clearance?

DIGITAL RETINAL CAMERA, CR-1 MARK II received FDA 510(k) clearance on 2009-03-23, under 510(k) number K090466.

Who is the listed applicant for DIGITAL RETINAL CAMERA, CR-1 MARK II?

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 RETINAL CAMERA, CR-1 MARK II?

The FDA product code for DIGITAL RETINAL CAMERA, CR-1 MARK II 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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