Falcon HST
K-Number: K242447 · 2025-02-20
ApplicantCompumedics Limited
Decision Date2025-02-20
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Falcon HST is a medical device manufactured by Compumedics Limited. It received FDA 510(k) clearance on 2025-02-20 under approval number K242447. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Falcon HST?
Falcon HST is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Compumedics Limited. The 510(k) number is K242447.
When was Falcon HST approved by the FDA?
Falcon HST received FDA 510(k) clearance on 2025-02-20, under approval number K242447.
What company makes Falcon HST?
Falcon HST is manufactured by Compumedics Limited.
What is the FDA product code for Falcon HST?
The FDA product code for Falcon HST is OLV.
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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.