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FDA 510(k)

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER

K-Number: K032799 · 2004-01-20

ApplicantReichert, Inc.
Decision Date2004-01-20
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Reichert, Inc.. It received FDA 510(k) clearance on 2004-01-20 under 510(k) number K032799. 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 NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER?

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER is a medical device that received FDA 510(k) clearance on 2004-01-20. The listed applicant is Reichert, Inc.. The 510(k) number is K032799.

When did NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER receive FDA 510(k) clearance?

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER received FDA 510(k) clearance on 2004-01-20, under 510(k) number K032799.

Who is the listed applicant for NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER?

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

What is the FDA product code for NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER?

The FDA product code for NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER is HKX.

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Other records listing Reichert, Inc. as applicant

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K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)K081756OCULAR RESPONSE ANALYZERK071839SOCT COPERNICUS, MODEL 15205K070534MODIFICATION TO: OCU-FILM TIP COVERK063750XCEL 255 SLIT LAMPK061330PSL PORTABLE SLIT LAMP

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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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