iCare ST500 (TA04)
K-Number: K241447 · 2024-09-27
ApplicantIcare Finland OY
Decision Date2024-09-27
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
iCare ST500 (TA04) is a medical device manufactured by Icare Finland OY. It received FDA 510(k) clearance on 2024-09-27 under approval number K241447. 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 ST500 (TA04)?
iCare ST500 (TA04) is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by Icare Finland OY. The 510(k) number is K241447.
When was iCare ST500 (TA04) approved by the FDA?
iCare ST500 (TA04) received FDA 510(k) clearance on 2024-09-27, under approval number K241447.
What company makes iCare ST500 (TA04)?
iCare ST500 (TA04) is manufactured by Icare Finland OY.
What is the FDA product code for iCare ST500 (TA04)?
The FDA product code for iCare ST500 (TA04) 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.