FDA 510(k)

DIAGNOSTIC ULTRASOUND/URO-GYN UD 511

K-Number: K911166 · 1991-08-15

Decision Date1991-08-15

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Ultrasound Corp.. It received FDA 510(k) clearance on 1991-08-15 under 510(k) number K911166. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTIC ULTRASOUND/URO-GYN UD 511?

DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 is a medical device that received FDA 510(k) clearance on 1991-08-15. The listed applicant is Diagnostic Ultrasound Corp.. The 510(k) number is K911166.

When did DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 received FDA 510(k) clearance on 1991-08-15, under 510(k) number K911166.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND/URO-GYN UD 511?

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

What is the FDA product code for DIAGNOSTIC ULTRASOUND/URO-GYN UD 511?

The FDA product code for DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 is DXT.

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Official Source

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