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FDA 510(k)

TRUEFIELD ANALYZER

K-Number: K063310 · 2007-08-02

ApplicantSeeing Machines Limited
Decision Date2007-08-02
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRUEFIELD ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Seeing Machines Limited. It received FDA 510(k) clearance on 2007-08-02 under 510(k) number K063310. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUEFIELD ANALYZER?

TRUEFIELD ANALYZER is a medical device that received FDA 510(k) clearance on 2007-08-02. The listed applicant is Seeing Machines Limited. The 510(k) number is K063310.

When did TRUEFIELD ANALYZER receive FDA 510(k) clearance?

TRUEFIELD ANALYZER received FDA 510(k) clearance on 2007-08-02, under 510(k) number K063310.

Who is the listed applicant for TRUEFIELD ANALYZER?

The FDA 510(k) record lists Seeing Machines Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUEFIELD ANALYZER?

The FDA product code for TRUEFIELD ANALYZER is HPT.

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Related Devices (Code: HPT)

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.

K092187MAIA, MODEL 1Centervue S.P.A.K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.K091579FORESEE HOMENotal Vision , Ltd.K050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.K023623NOVAVISION, MODEL 2.0Novavision, Inc.K971156KASHA VISUAL FIELD SYSTEMKasha Software, 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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