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FDA 510(k)

B-Ultrasound Diagnostic System

K-Number: K232895 · 2024-05-03

ApplicantContec Medical Systems Co.,Ltd
Decision Date2024-05-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

B-Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K232895. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-Ultrasound Diagnostic System?

B-Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K232895.

When did B-Ultrasound Diagnostic System receive FDA 510(k) clearance?

B-Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232895.

Who is the listed applicant for B-Ultrasound Diagnostic System?

The FDA 510(k) record lists Contec Medical Systems Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-Ultrasound Diagnostic System?

The FDA product code for B-Ultrasound Diagnostic System is IYO.

Other records listing Contec 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.

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Related Devices (Code: IYO)

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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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