FDA 510(k)

PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS

K-Number: K110482 · 2011-03-18

Decision Date2011-03-18

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corp.. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K110482. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS?

PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Teratech Corp.. The 510(k) number is K110482.

When did PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS receive FDA 510(k) clearance?

PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS received FDA 510(k) clearance on 2011-03-18, under 510(k) number K110482.

Who is the listed applicant for PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS?

The FDA 510(k) record lists Teratech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS?

The FDA product code for PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS is IYN.

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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.