FDA 510(k)

Applanation Tonometer HT-5000

K-Number: K232143 · 2023-10-23

Decision Date2023-10-23

Product CodeHKY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Applanation Tonometer HT-5000 is a medical device manufactured by Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2023-10-23 under approval number K232143. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Applanation Tonometer HT-5000?

Applanation Tonometer HT-5000 is a medical device that received FDA 510(k) clearance on 2023-10-23. It is manufactured by Huvitz Co., Ltd.. The 510(k) number is K232143.

When was Applanation Tonometer HT-5000 approved by the FDA?

Applanation Tonometer HT-5000 received FDA 510(k) clearance on 2023-10-23, under approval number K232143.

What company makes Applanation Tonometer HT-5000?

Applanation Tonometer HT-5000 is manufactured by Huvitz Co., Ltd..

What is the FDA product code for Applanation Tonometer HT-5000?

The FDA product code for Applanation Tonometer HT-5000 is HKY.

Related Clinical Trials

NCT05523622 Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices RECRUITING NCT04639947 Reliability and Reproducibility of the Eye Check Tonometer TERMINATED

Other Devices by Huvitz Co., Ltd.

K161829Huvitz Imaging System K191615Huvitz Imaging System K202097Fundus Camera

Related Devices (Code: HKY)

K153694Icare ic100Icare Finland OY K142263Applanation TonometerShanghai Mediworks Precision Instruments Co. , Ltd. K151491Falck Medical Multifunction Tonometer, FAT1Falck Medical, Inc. K172728Applanation tonometer AT-1Takagi Seiko Co., Ltd. K163343Icare HOME tonometerIcare Finland OY K182491Applanation tonometer AT-2Takagi Seiko Co., Ltd.

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.