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FDA 510(k)

CATS-L Tonometer™ Prism

K-Number: K234037 · 2024-02-09

ApplicantCats Tonometer, LLC
Decision Date2024-02-09
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CATS-L Tonometer™ Prism is the device name listed in this FDA 510(k) record. The listed applicant is Cats Tonometer, LLC. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K234037. 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 CATS-L Tonometer™ Prism?

CATS-L Tonometer™ Prism is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Cats Tonometer, LLC. The 510(k) number is K234037.

When did CATS-L Tonometer™ Prism receive FDA 510(k) clearance?

CATS-L Tonometer™ Prism received FDA 510(k) clearance on 2024-02-09, under 510(k) number K234037.

Who is the listed applicant for CATS-L Tonometer™ Prism?

The FDA 510(k) record lists Cats Tonometer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATS-L Tonometer™ Prism?

The FDA product code for CATS-L Tonometer™ Prism is HKY.

Other records listing Cats Tonometer, LLC 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.

K203850CATS®-D Tonometer PrismK173904CATS Tonometer Prism

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.K232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare 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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