FDA 510(k)

Tono Vue Non-Contact Tonometer

K-Number: K180820 · 2018-12-14

Decision Date2018-12-14

Product CodeHKX

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Tono Vue Non-Contact Tonometer is a medical device manufactured by Crystalvue Medical Corporation. It received FDA 510(k) clearance on 2018-12-14 under approval number K180820. 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 Tono Vue Non-Contact Tonometer?

Tono Vue Non-Contact Tonometer is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Crystalvue Medical Corporation. The 510(k) number is K180820.

When was Tono Vue Non-Contact Tonometer approved by the FDA?

Tono Vue Non-Contact Tonometer received FDA 510(k) clearance on 2018-12-14, under approval number K180820.

What company makes Tono Vue Non-Contact Tonometer?

Tono Vue Non-Contact Tonometer is manufactured by Crystalvue Medical Corporation.

What is the FDA product code for Tono Vue Non-Contact Tonometer?

The FDA product code for Tono Vue Non-Contact Tonometer is HKX.

Other Devices by Crystalvue Medical Corporation

K182199NFC-700 non-mydriatic auto fundus camera K210197NFC-600 Automated Portable Retinal Camera

Related Devices (Code: HKX)

K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas K190382Intraocular Pressure Tonometer EASYTONCompany Elamed K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis) K181143Keeler TonoCare TonometerKeeler Instruments, Inc. K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon 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.