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FDA 510(k)

Icare HOME Tonometer

K-Number: K200966 · 2020-05-07

ApplicantIcare Finland OY
Decision Date2020-05-07
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Icare HOME Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Icare Finland OY. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K200966. 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 Icare HOME Tonometer?

Icare HOME Tonometer is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Icare Finland OY. The 510(k) number is K200966.

When did Icare HOME Tonometer receive FDA 510(k) clearance?

Icare HOME Tonometer received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200966.

Who is the listed applicant for Icare HOME Tonometer?

The FDA 510(k) record lists Icare Finland OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Icare HOME Tonometer?

The FDA product code for Icare HOME Tonometer is HKY.

Related Clinical Trials

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.

NCT07629232Measuring Corneal ParametersRECRUITING

Other records listing Icare Finland OY 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.

K241447iCare ST500 (TA04)K220852iCare IC200K211355iCare HOME2K190316Icare ic200K163343Icare HOME tonometerK153694Icare ic100

View all 7 devices →

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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