Definium Tempo Select
K-Number: K250788 · 2025-08-28
Device Summary
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. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K250788.
When did Definium Tempo Select receive FDA 510(k) clearance?
Definium Tempo Select received FDA 510(k) clearance on 2025-08-28, under 510(k) number K250788.
Who is the listed applicant for Definium Tempo Select?
The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Definium Tempo Select?
The FDA product code for Definium Tempo Select is KPR.
Other records listing Ge Hualun Medical Systems Co. , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: KPR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.