Icare ic200
K-Number: K190316 · 2020-01-14
ApplicantIcare Finland OY
Decision Date2020-01-14
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 2020-01-14 under approval number K190316. 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 2020-01-14. It is manufactured by Icare Finland OY. The 510(k) number is K190316.
When was Icare ic200 approved by the FDA?
Icare ic200 received FDA 510(k) clearance on 2020-01-14, under approval number K190316.
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
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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.