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FDA 510(k)

Keeler TonoCare Tonometer

K-Number: K181143 · 2019-02-08

ApplicantKeeler Instruments, Inc.
Decision Date2019-02-08
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Keeler TonoCare Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K181143. 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 Keeler TonoCare Tonometer?

Keeler TonoCare Tonometer is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K181143.

When did Keeler TonoCare Tonometer receive FDA 510(k) clearance?

Keeler TonoCare Tonometer received FDA 510(k) clearance on 2019-02-08, under 510(k) number K181143.

Who is the listed applicant for Keeler TonoCare Tonometer?

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

What is the FDA product code for Keeler TonoCare Tonometer?

The FDA product code for Keeler TonoCare Tonometer is HKX.

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)K180820Tono Vue Non-Contact TonometerCrystalvue Medical CorporationK162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas

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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