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FDA 510(k)

FULL AUTO TONOMETER MODEL TX-20

K-Number: K111710 · 2011-09-20

ApplicantCanon Inc. -Medical Equipment Group
Decision Date2011-09-20
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FULL AUTO TONOMETER MODEL TX-20 is the device name listed in this FDA 510(k) record. The listed applicant is Canon Inc. -Medical Equipment Group. It received FDA 510(k) clearance on 2011-09-20 under 510(k) number K111710. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULL AUTO TONOMETER MODEL TX-20?

FULL AUTO TONOMETER MODEL TX-20 is a medical device that received FDA 510(k) clearance on 2011-09-20. The listed applicant is Canon Inc. -Medical Equipment Group. The 510(k) number is K111710.

When did FULL AUTO TONOMETER MODEL TX-20 receive FDA 510(k) clearance?

FULL AUTO TONOMETER MODEL TX-20 received FDA 510(k) clearance on 2011-09-20, under 510(k) number K111710.

Who is the listed applicant for FULL AUTO TONOMETER MODEL TX-20?

The FDA 510(k) record lists Canon Inc. -Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL AUTO TONOMETER MODEL TX-20?

The FDA product code for FULL AUTO TONOMETER MODEL TX-20 is HKX.

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Other records listing Canon Inc. -Medical Equipment Group as applicant

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Related Devices (Code: HKX)

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.

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon CorporationK223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany ElamedK181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation

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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