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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 the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-06-10 under 510(k) 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. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K240206.

When did Venue Sprint receive FDA 510(k) clearance?

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

Who is the listed applicant for Venue Sprint?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venue Sprint?

The FDA product code for Venue Sprint is IYN.

Other records listing GE Medical Systems Ultrasound and Primary Care Diagnostics 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.

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Related Devices (Code: IYN)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.