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FDA 510(k)

60 FUNDUS CAMERA CF-60UV

K-Number: K946058 · 1995-02-03

ApplicantCanon USA, Inc.
Decision Date1995-02-03
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

60 FUNDUS CAMERA CF-60UV 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 1995-02-03 under 510(k) number K946058. 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 60 FUNDUS CAMERA CF-60UV?

60 FUNDUS CAMERA CF-60UV is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Canon USA, Inc.. The 510(k) number is K946058.

When did 60 FUNDUS CAMERA CF-60UV receive FDA 510(k) clearance?

60 FUNDUS CAMERA CF-60UV received FDA 510(k) clearance on 1995-02-03, under 510(k) number K946058.

Who is the listed applicant for 60 FUNDUS CAMERA CF-60UV?

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 60 FUNDUS CAMERA CF-60UV?

The FDA product code for 60 FUNDUS CAMERA CF-60UV is HKI.

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Other records listing Canon USA, Inc. as applicant

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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: 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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