iCare HOME2
K-Number: K211355 · 2022-01-25
ApplicantIcare Finland OY
Decision Date2022-01-25
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
iCare HOME2 is a medical device manufactured by Icare Finland OY. It received FDA 510(k) clearance on 2022-01-25 under approval number K211355. 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 HOME2?
iCare HOME2 is a medical device that received FDA 510(k) clearance on 2022-01-25. It is manufactured by Icare Finland OY. The 510(k) number is K211355.
When was iCare HOME2 approved by the FDA?
iCare HOME2 received FDA 510(k) clearance on 2022-01-25, under approval number K211355.
What company makes iCare HOME2?
iCare HOME2 is manufactured by Icare Finland OY.
What is the FDA product code for iCare HOME2?
The FDA product code for iCare HOME2 is HKY.
Other Devices by Icare Finland OY
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K163343Icare HOME tonometerIcare Finland OY
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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.