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FDA 510(k)

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS

K-Number: K963065 · 1997-05-29

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

Device Summary

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS 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 K963065. 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-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS?

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS 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 K963065.

When did CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS receive FDA 510(k) clearance?

CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS received FDA 510(k) clearance on 1997-05-29, under 510(k) number K963065.

Who is the listed applicant for CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS?

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-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS?

The FDA product code for CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS is 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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