Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Definium Pace Select ET

K-Number: K242678 · 2024-10-01

Decision Date2024-10-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Definium Pace Select ET is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K242678. 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 ET?

Definium Pace Select ET is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K242678.

When did Definium Pace Select ET receive FDA 510(k) clearance?

Definium Pace Select ET received FDA 510(k) clearance on 2024-10-01, under 510(k) number K242678.

Who is the listed applicant for Definium Pace Select ET?

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 Pace Select ET?

The FDA product code for Definium Pace Select ET 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.

View all 11 devices →

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.