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FDA 510(k)

DIGITAL RETINAL CAMERA CX-1

K-Number: K092565 · 2010-03-18

ApplicantCanon Components, Inc.
Decision Date2010-03-18
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGITAL RETINAL CAMERA CX-1 is the device name listed in this FDA 510(k) record. The listed applicant is Canon Components, Inc.. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K092565. 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 CX-1?

DIGITAL RETINAL CAMERA CX-1 is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Canon Components, Inc.. The 510(k) number is K092565.

When did DIGITAL RETINAL CAMERA CX-1 receive FDA 510(k) clearance?

DIGITAL RETINAL CAMERA CX-1 received FDA 510(k) clearance on 2010-03-18, under 510(k) number K092565.

Who is the listed applicant for DIGITAL RETINAL CAMERA CX-1?

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

What is the FDA product code for DIGITAL RETINAL CAMERA CX-1?

The FDA product code for DIGITAL RETINAL CAMERA CX-1 is HKI.

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Related Devices (Code: HKI)

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Official Source

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

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