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FDA 510(k)

CTS-200 WITH EZU-PL21 TRANSDUCER

K-Number: K963068 · 1997-05-29

ApplicantShantou Institute of Ultrasonic Instuments
Decision Date1997-05-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTS-200 WITH EZU-PL21 TRANSDUCER 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 1997-05-29 under 510(k) number K963068. 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-200 WITH EZU-PL21 TRANSDUCER?

CTS-200 WITH EZU-PL21 TRANSDUCER is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is Shantou Institute of Ultrasonic Instuments. The 510(k) number is K963068.

When did CTS-200 WITH EZU-PL21 TRANSDUCER receive FDA 510(k) clearance?

CTS-200 WITH EZU-PL21 TRANSDUCER received FDA 510(k) clearance on 1997-05-29, under 510(k) number K963068.

Who is the listed applicant for CTS-200 WITH EZU-PL21 TRANSDUCER?

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-200 WITH EZU-PL21 TRANSDUCER?

The FDA product code for CTS-200 WITH EZU-PL21 TRANSDUCER is IYO.

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Other records listing Shantou Institute of Ultrasonic Instuments as applicant

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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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