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FDA 510(k)

NON-CONTACT TONOMETER, MODEL FT-1000

K-Number: K073087 · 2008-11-18

ApplicantTomey Corporation
Decision Date2008-11-18
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NON-CONTACT TONOMETER, MODEL FT-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2008-11-18 under 510(k) number K073087. 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 TONOMETER, MODEL FT-1000?

NON-CONTACT TONOMETER, MODEL FT-1000 is a medical device that received FDA 510(k) clearance on 2008-11-18. The listed applicant is Tomey Corporation. The 510(k) number is K073087.

When did NON-CONTACT TONOMETER, MODEL FT-1000 receive FDA 510(k) clearance?

NON-CONTACT TONOMETER, MODEL FT-1000 received FDA 510(k) clearance on 2008-11-18, under 510(k) number K073087.

Who is the listed applicant for NON-CONTACT TONOMETER, MODEL FT-1000?

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

What is the FDA product code for NON-CONTACT TONOMETER, MODEL FT-1000?

The FDA product code for NON-CONTACT TONOMETER, MODEL FT-1000 is HKX.

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Other records listing Tomey Corporation 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.

K252348Tomey Optical Biometer OA-2000 (OA-2000)K250553Tomey Cornea/Anterior Segment OCT (CASIA2)K213265Tomey Cornea/Anterior Segment OCT CASIA2K171313EM-4000 Specular Microscope

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

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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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