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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 a medical device manufactured by Icare Finland OY. It received FDA 510(k) clearance on 2022-10-06 under approval 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. It is manufactured by Icare Finland OY. The 510(k) number is K220852.

When was iCare IC200 approved by the FDA?

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

What company makes iCare IC200?

iCare IC200 is manufactured by Icare Finland OY.

What is the FDA product code for iCare IC200?

The FDA product code for iCare IC200 is HKY.

Other Devices by Icare Finland OY

K153694Icare ic100 K163343Icare HOME tonometer K200966Icare HOME Tonometer K190316Icare ic200 K211355iCare HOME2 K241447iCare ST500 (TA04)

View all 7 devices →

Related Devices (Code: HKY)

K153694Icare ic100Icare Finland OY K142263Applanation TonometerShanghai Mediworks Precision Instruments Co. , Ltd. K151491Falck Medical Multifunction Tonometer, FAT1Falck Medical, Inc. K172728Applanation tonometer AT-1Takagi Seiko Co., Ltd. K163343Icare HOME tonometerIcare Finland OY K182491Applanation tonometer AT-2Takagi Seiko Co., Ltd.

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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