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FDA 510(k)

CTS-7700

K-Number: K061083 · 2006-06-06

ApplicantShantou Institute of Ultrasonic Instuments
Decision Date2006-06-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTS-7700 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 2006-06-06 under 510(k) number K061083. 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-7700?

CTS-7700 is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Shantou Institute of Ultrasonic Instuments. The 510(k) number is K061083.

When did CTS-7700 receive FDA 510(k) clearance?

CTS-7700 received FDA 510(k) clearance on 2006-06-06, under 510(k) number K061083.

Who is the listed applicant for CTS-7700?

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-7700?

The FDA product code for CTS-7700 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.

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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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