FDA 510(k)

TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM

K-Number: K946277 · 1996-03-15

Decision Date1996-03-15

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tetra Corp.. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K946277. 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 TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM?

TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Tetra Corp.. The 510(k) number is K946277.

When did TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM receive FDA 510(k) clearance?

TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM received FDA 510(k) clearance on 1996-03-15, under 510(k) number K946277.

Who is the listed applicant for TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM?

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 TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM?

The FDA product code for TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM is IYN.

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Other records listing Tetra Corp. as applicant

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 K924204NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS

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.