Uroview

FDA 510(k) K872022 · Oec-Diasonics, Inc.

Substantially Equivalent

510(k) numberK872022

Submission

Device name
Uroview
Applicant
Oec-Diasonics, Inc.
Salt Lake City, UT, US
Received
May 26, 1987
Decision date
July 16, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KQS – Table, Cystometric, Non-Electric And Accessories
Device class
Class I (low risk)
Regulation
21 CFR 876.4890
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KQS

510(k)DeviceApplicantDecision
K955019Urotract IKQS · Traditional Dornier Medtech America, Inc.12/06/1995SE
K864846Radiographic - Leg SectionKQS · Traditional American Sterilizer Co.12/24/1986SE
K860040Hydrajust III Urological TableKQS · Traditional Mallinckrodt Group, Inc.02/10/1986SE
K852127Amsco Uro-Endo Mobile TableKQS · Traditional American Sterilizer Co.08/08/1985SE
K801723Ur 150-UR 150TKQS · Traditional Siemens Corp.08/13/1980SE
K791699Hydradjust II Urological TableKQS · Traditional Sybron Corp.10/22/1979SE
K760522Table, UrosurgicalKQS · Traditional Mallinckrodt Group, Inc.12/16/1976SE

More from Mallinckrodt Group, Inc.

510(k)DeviceDecision
K9260569600 Fluoroscopic Imaging SystemOXO · Traditional 01/21/1993SE
K924879Ep 3000JAA · Traditional 01/04/1993SE
K914446Uroview 2000, ModificationJAA · Traditional 01/10/1992SE
K896583F.A.S.T. TableIXR · Traditional 03/01/1990SE
K893475Uroview IIJAA · Traditional 08/10/1989SE
K864837Modified Mainframe of Model 902 Mobile C-ArmJAA · Traditional 01/30/1987SE
K843972Angioplus-SJAA · Traditional 01/03/1985SE

Questions and answers

When was Uroview cleared by the FDA?

Uroview (K872022) received a 510(k) decision of Substantially Equivalent on July 16, 1987, 51 days after the submission was received.

What is the product code of K872022?

The FDA product code is KQS – Table, Cystometric, Non-Electric And Accessories, a Class I (low risk) device regulated under 21 CFR 876.4890.