FDA 510(k)

ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER

K-Number: K042326 · 2004-09-16

Decision Date2004-09-16

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasonix Medical Corporation. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K042326. 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 ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER?

ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Ultrasonix Medical Corporation. The 510(k) number is K042326.

When did ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER receive FDA 510(k) clearance?

ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042326.

Who is the listed applicant for ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER?

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

What is the FDA product code for ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER?

The FDA product code for ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER 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.