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FDA 510(k)

Applanation Tonometer HT-5000

K-Number: K232143 · 2023-10-23

ApplicantHuvitz Co., Ltd.
Decision Date2023-10-23
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Applanation Tonometer HT-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2023-10-23 under 510(k) 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. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K232143.

When did Applanation Tonometer HT-5000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Applanation Tonometer HT-5000?

The FDA 510(k) record lists Huvitz Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Huvitz Co., Ltd. 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.

K202097Fundus CameraK191615Huvitz Imaging SystemK161829Huvitz Imaging System

Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OYK203850CATS®-D Tonometer PrismCats Tonometer, LLC

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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