Definium Tempo Select
K-Number: K250788 · 2025-08-28
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2025-08-28
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Definium Tempo Select is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2025-08-28 under approval number K250788. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Definium Tempo Select?
Definium Tempo Select is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K250788.
When was Definium Tempo Select approved by the FDA?
Definium Tempo Select received FDA 510(k) clearance on 2025-08-28, under approval number K250788.
What company makes Definium Tempo Select?
Definium Tempo Select is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for Definium Tempo Select?
The FDA product code for Definium Tempo Select is KPR.
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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.