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FDA 510(k)

FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440

K-Number: K093071 · 2010-11-17

ApplicantFundus Photo, LLC
Decision Date2010-11-17
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 is the device name listed in this FDA 510(k) record. The listed applicant is Fundus Photo, LLC. It received FDA 510(k) clearance on 2010-11-17 under 510(k) number K093071. 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 FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440?

FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 is a medical device that received FDA 510(k) clearance on 2010-11-17. The listed applicant is Fundus Photo, LLC. The 510(k) number is K093071.

When did FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 receive FDA 510(k) clearance?

FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 received FDA 510(k) clearance on 2010-11-17, under 510(k) number K093071.

Who is the listed applicant for FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440?

The FDA 510(k) record lists Fundus Photo, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440?

The FDA product code for FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 is HKI.

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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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