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FDA 510(k)

CANON AUTO REF-KERATOMETER RK-2

K-Number: K895475 · 1989-10-31

ApplicantCanon USA, Inc.
Decision Date1989-10-31
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CANON AUTO REF-KERATOMETER RK-2 is the device name listed in this FDA 510(k) record. The listed applicant is Canon USA, Inc.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895475. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANON AUTO REF-KERATOMETER RK-2?

CANON AUTO REF-KERATOMETER RK-2 is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Canon USA, Inc.. The 510(k) number is K895475.

When did CANON AUTO REF-KERATOMETER RK-2 receive FDA 510(k) clearance?

CANON AUTO REF-KERATOMETER RK-2 received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895475.

Who is the listed applicant for CANON AUTO REF-KERATOMETER RK-2?

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

What is the FDA product code for CANON AUTO REF-KERATOMETER RK-2?

The FDA product code for CANON AUTO REF-KERATOMETER RK-2 is HLQ.

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Other records listing Canon USA, 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.

K090623DIGITAL RADIOGRAPHY CXDI-40G COMPACTK033624PACS SOFTWARE SOLUTION 2003K031633CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40CK031629CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGIK023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40GK023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

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Related Devices (Code: HLQ)

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.

K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000Nidek Co., Ltd.K973756EYE SYS VISTAEyesys Technologies, Inc.K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical Marketinig

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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