FDA 510(k)

NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS

K-Number: K924204 · 1993-06-07

Decision Date1993-06-07

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Tetra Corp.. It received FDA 510(k) clearance on 1993-06-07 under 510(k) number K924204. 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 NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS?

NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS is a medical device that received FDA 510(k) clearance on 1993-06-07. The listed applicant is Tetra Corp.. The 510(k) number is K924204.

When did NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS receive FDA 510(k) clearance?

NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS received FDA 510(k) clearance on 1993-06-07, under 510(k) number K924204.

Who is the listed applicant for NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS?

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

What is the FDA product code for NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS?

The FDA product code for NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS is IYN.

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Other records listing Tetra Corp. as applicant

K946277TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM K945320TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL K945318TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA K945319TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.