Icare HOME tonometer
K-Number: K163343 · 2017-03-21
ApplicantIcare Finland OY
Decision Date2017-03-21
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Icare HOME tonometer is a medical device manufactured by Icare Finland OY. It received FDA 510(k) clearance on 2017-03-21 under approval number K163343. 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 HOME tonometer?
Icare HOME tonometer is a medical device that received FDA 510(k) clearance on 2017-03-21. It is manufactured by Icare Finland OY. The 510(k) number is K163343.
When was Icare HOME tonometer approved by the FDA?
Icare HOME tonometer received FDA 510(k) clearance on 2017-03-21, under approval number K163343.
What company makes Icare HOME tonometer?
Icare HOME tonometer is manufactured by Icare Finland OY.
What is the FDA product code for Icare HOME tonometer?
The FDA product code for Icare HOME tonometer 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.