MCT Medical Browne Uroscan Urodynamic

FDA 510(k) K880504 · Mct Medical, Inc.

Substantially Equivalent

510(k) numberK880504

Submission

Device name
MCT Medical Browne Uroscan Urodynamic
Applicant
Mct Medical, Inc.
Shoreview, MN, US
Received
February 5, 1988
Decision date
June 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EXY – Uroflowmeter
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1800
Specialty
Gastroenterology, Urology

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Questions and answers

When was MCT Medical Browne Uroscan Urodynamic cleared by the FDA?

MCT Medical Browne Uroscan Urodynamic (K880504) received a 510(k) decision of Substantially Equivalent on June 17, 1988, 133 days after the submission was received.

What is the product code of K880504?

The FDA product code is EXY – Uroflowmeter, a Class II (moderate risk) device regulated under 21 CFR 876.1800.