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FDA 510(k)

CTS-415

K-Number: K013327 · 2001-12-14

ApplicantShantou Institute of Ultrasonic Instuments
Decision Date2001-12-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTS-415 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 2001-12-14 under 510(k) number K013327. 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-415?

CTS-415 is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is Shantou Institute of Ultrasonic Instuments. The 510(k) number is K013327.

When did CTS-415 receive FDA 510(k) clearance?

CTS-415 received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013327.

Who is the listed applicant for CTS-415?

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-415?

The FDA product code for CTS-415 is IYO.

Other records listing Shantou Institute of Ultrasonic Instuments as applicant

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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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