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FDA 510(k)

CTS-310(B)

K-Number: K984161 · 1999-05-05

ApplicantShantou Institute of Ultrasonic Instuments
Decision Date1999-05-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTS-310(B) is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instuments. It received FDA 510(k) clearance on 1999-05-05 under 510(k) number K984161. 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 CTS-310(B)?

CTS-310(B) is a medical device that received FDA 510(k) clearance on 1999-05-05. The listed applicant is Shantou Institute of Ultrasonic Instuments. The 510(k) number is K984161.

When did CTS-310(B) receive FDA 510(k) clearance?

CTS-310(B) received FDA 510(k) clearance on 1999-05-05, under 510(k) number K984161.

Who is the listed applicant for CTS-310(B)?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instuments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CTS-310(B)?

The FDA product code for CTS-310(B) is IYO.

Other records listing Shantou Institute of Ultrasonic Instuments 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.

K113613DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEMK092907DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARRK081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEMK070982CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEMK061083CTS-7700K013327CTS-415

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Related Devices (Code: IYO)

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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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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