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FDA 510(k)

CATS Tonometer Prism

K-Number: K173904 · 2018-03-09

ApplicantCats Tonometer, LLC
Decision Date2018-03-09
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CATS 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 2018-03-09 under 510(k) number K173904. 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 Tonometer Prism?

CATS Tonometer Prism is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Cats Tonometer, LLC. The 510(k) number is K173904.

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

CATS Tonometer Prism received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173904.

Who is the listed applicant for CATS 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 Tonometer Prism?

The FDA product code for CATS 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.

K234037CATS-L Tonometer™ PrismK203850CATS®-D 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.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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