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

FDA 510(k)

Venue Sprint

K-Number: K240206 · 2024-06-10

Decision Date2024-06-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Venue Sprint is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-06-10 under approval number K240206. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venue Sprint?

Venue Sprint is a medical device that received FDA 510(k) clearance on 2024-06-10. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K240206.

When was Venue Sprint approved by the FDA?

Venue Sprint received FDA 510(k) clearance on 2024-06-10, under approval number K240206.

What company makes Venue Sprint?

Venue Sprint is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for Venue Sprint?

The FDA product code for Venue Sprint is IYN.

Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics

View all 61 devices →

Related Devices (Code: IYN)

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.