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FDA 510(k)

Ultrasonic Gastrovideoscope

K-Number: K231813 · 2024-03-08

ApplicantSonoscape Medical Corp.
Decision Date2024-03-08
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Gastrovideoscope is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2024-03-08 under approval number K231813. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Gastrovideoscope?

Ultrasonic Gastrovideoscope is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K231813.

When was Ultrasonic Gastrovideoscope approved by the FDA?

Ultrasonic Gastrovideoscope received FDA 510(k) clearance on 2024-03-08, under approval number K231813.

What company makes Ultrasonic Gastrovideoscope?

Ultrasonic Gastrovideoscope is manufactured by Sonoscape Medical Corp..

What is the FDA product code for Ultrasonic Gastrovideoscope?

The FDA product code for Ultrasonic Gastrovideoscope is ODG.

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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.

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