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FDA 510(k)

CANON TX-10 TONOMETER

K-Number: K963079 · 1997-03-03

ApplicantCanon USA, Inc.
Decision Date1997-03-03
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CANON TX-10 TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Canon USA, Inc.. It received FDA 510(k) clearance on 1997-03-03 under 510(k) number K963079. 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 CANON TX-10 TONOMETER?

CANON TX-10 TONOMETER is a medical device that received FDA 510(k) clearance on 1997-03-03. The listed applicant is Canon USA, Inc.. The 510(k) number is K963079.

When did CANON TX-10 TONOMETER receive FDA 510(k) clearance?

CANON TX-10 TONOMETER received FDA 510(k) clearance on 1997-03-03, under 510(k) number K963079.

Who is the listed applicant for CANON TX-10 TONOMETER?

The FDA 510(k) record lists Canon USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANON TX-10 TONOMETER?

The FDA product code for CANON TX-10 TONOMETER is HKX.

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Other records listing Canon USA, Inc. 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.

K090623DIGITAL RADIOGRAPHY CXDI-40G COMPACTK033624PACS SOFTWARE SOLUTION 2003K031633CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40CK031629CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGIK023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40GK023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

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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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