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FDA 510(k)

NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL

K-Number: K895474 · 1989-10-04

ApplicantCanon USA, Inc.
Decision Date1989-10-04
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL 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 1989-10-04 under 510(k) number K895474. 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 NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL?

NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Canon USA, Inc.. The 510(k) number is K895474.

When did NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL receive FDA 510(k) clearance?

NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL received FDA 510(k) clearance on 1989-10-04, under 510(k) number K895474.

Who is the listed applicant for NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL?

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 NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL?

The FDA product code for NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL is HKI.

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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: 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

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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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