Knoll/Midus (Male Impotence Diagnostic Ultrasonic System)

FDA 510(k) K971790 · Urometrics, Inc.

Substantially Equivalent

510(k) numberK971790

Submission

Device name
Knoll/Midus (Male Impotence Diagnostic Ultrasonic System)
Applicant
Urometrics, Inc.
St. Paul, MN, US
Received
May 14, 1997
Decision date
December 17, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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Questions and answers

When was Knoll/Midus (Male Impotence Diagnostic Ultrasonic System) cleared by the FDA?

Knoll/Midus (Male Impotence Diagnostic Ultrasonic System) (K971790) received a 510(k) decision of Substantially Equivalent on December 17, 1997, 217 days after the submission was received.

What is the product code of K971790?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.