Clearo
K-Number: K242438 · 2025-05-16
ApplicantBreas Medical AB
Decision Date2025-05-16
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Clearo is a medical device manufactured by Breas Medical AB. It received FDA 510(k) clearance on 2025-05-16 under approval number K242438. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Clearo?
Clearo is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Breas Medical AB. The 510(k) number is K242438.
When was Clearo approved by the FDA?
Clearo received FDA 510(k) clearance on 2025-05-16, under approval number K242438.
What company makes Clearo?
Clearo is manufactured by Breas Medical AB.
What is the FDA product code for Clearo?
The FDA product code for Clearo is NHJ.
Other Devices by Breas Medical AB
Related Devices (Code: NHJ)
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.