Definium Pace Select
K-Number: K231892 · 2023-09-12
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2023-09-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Definium Pace Select is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2023-09-12 under approval number K231892. 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 Pace Select?
Definium Pace Select is a medical device that received FDA 510(k) clearance on 2023-09-12. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K231892.
When was Definium Pace Select approved by the FDA?
Definium Pace Select received FDA 510(k) clearance on 2023-09-12, under approval number K231892.
What company makes Definium Pace Select?
Definium Pace Select is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for Definium Pace Select?
The FDA product code for Definium Pace 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.