Icare ic100
K-Number: K153694 · 2016-04-19
ApplicantIcare Finland OY
Decision Date2016-04-19
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Icare ic100 is a medical device manufactured by Icare Finland OY. It received FDA 510(k) clearance on 2016-04-19 under approval number K153694. 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 ic100?
Icare ic100 is a medical device that received FDA 510(k) clearance on 2016-04-19. It is manufactured by Icare Finland OY. The 510(k) number is K153694.
When was Icare ic100 approved by the FDA?
Icare ic100 received FDA 510(k) clearance on 2016-04-19, under approval number K153694.
What company makes Icare ic100?
Icare ic100 is manufactured by Icare Finland OY.
What is the FDA product code for Icare ic100?
The FDA product code for Icare ic100 is HKY.
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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.