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FDA 510(k)

iCare IC200

K-Number: K220852 · 2022-10-06

ApplicantIcare Finland OY
Decision Date2022-10-06
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iCare IC200 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 2022-10-06 under 510(k) number K220852. 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 IC200?

iCare IC200 is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Icare Finland OY. The 510(k) number is K220852.

When did iCare IC200 receive FDA 510(k) clearance?

iCare IC200 received FDA 510(k) clearance on 2022-10-06, under 510(k) number K220852.

Who is the listed applicant for iCare IC200?

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 IC200?

The FDA product code for iCare IC200 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)K211355iCare HOME2K200966Icare HOME TonometerK190316Icare 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.K211355iCare 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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