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FDA 510(k)

CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

K-Number: K101935 · 2010-10-27

ApplicantCentervue S.P.A.
Decision Date2010-10-27
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CENTERVUE DIGITAL RETINOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2010-10-27 under 510(k) number K101935. 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 CENTERVUE DIGITAL RETINOGRAPHY SYSTEM?

CENTERVUE DIGITAL RETINOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-27. The listed applicant is Centervue S.P.A.. The 510(k) number is K101935.

When did CENTERVUE DIGITAL RETINOGRAPHY SYSTEM receive FDA 510(k) clearance?

CENTERVUE DIGITAL RETINOGRAPHY SYSTEM received FDA 510(k) clearance on 2010-10-27, under 510(k) number K101935.

Who is the listed applicant for CENTERVUE DIGITAL RETINOGRAPHY SYSTEM?

The FDA 510(k) record lists Centervue S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTERVUE DIGITAL RETINOGRAPHY SYSTEM?

The FDA product code for CENTERVUE DIGITAL RETINOGRAPHY SYSTEM is HKI.

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Other records listing Centervue S.P.A. 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)

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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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