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FDA 510(k)

CR-1

K-Number: K080883 · 2008-04-24

ApplicantCanon, Inc.
Decision Date2008-04-24
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CR-1 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2008-04-24 under 510(k) number K080883. 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 CR-1?

CR-1 is a medical device that received FDA 510(k) clearance on 2008-04-24. The listed applicant is Canon, Inc.. The 510(k) number is K080883.

When did CR-1 receive FDA 510(k) clearance?

CR-1 received FDA 510(k) clearance on 2008-04-24, under 510(k) number K080883.

Who is the listed applicant for CR-1?

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 CR-1?

The FDA product code for CR-1 is HKI.

Other records listing Canon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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