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FDA 510(k)

FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM

K-Number: K011877 · 2001-09-26

ApplicantCarl Zeiss Jena GmbH
Decision Date2001-09-26
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Jena GmbH. It received FDA 510(k) clearance on 2001-09-26 under 510(k) number K011877. 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 FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM?

FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-26. The listed applicant is Carl Zeiss Jena GmbH. The 510(k) number is K011877.

When did FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM receive FDA 510(k) clearance?

FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM received FDA 510(k) clearance on 2001-09-26, under 510(k) number K011877.

Who is the listed applicant for FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM?

The FDA 510(k) record lists Carl Zeiss Jena GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM?

The FDA product code for FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM is HKI.

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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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