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FDA 510(k)

VS Tabletop Tonometer

K-Number: K223739 · 2023-11-08

ApplicantMedimaging Integrated Solution, Inc.
Decision Date2023-11-08
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VS Tabletop Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc.. It received FDA 510(k) clearance on 2023-11-08 under 510(k) number K223739. 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 VS Tabletop Tonometer?

VS Tabletop Tonometer is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Medimaging Integrated Solution, Inc.. The 510(k) number is K223739.

When did VS Tabletop Tonometer receive FDA 510(k) clearance?

VS Tabletop Tonometer received FDA 510(k) clearance on 2023-11-08, under 510(k) number K223739.

Who is the listed applicant for VS Tabletop Tonometer?

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

What is the FDA product code for VS Tabletop Tonometer?

The FDA product code for VS Tabletop 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 CorporationK190382Intraocular Pressure Tonometer EASYTONCompany ElamedK181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical CorporationK162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas

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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