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510(k) K872022

UROVIEW by Oec-Diasonics, Inc. — Product Code KQS

K872022 is an FDA 510(k) premarket notification submitted by Oec-Diasonics, Inc. for the device "UROVIEW". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. Oec-Diasonics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1987
Date Received
May 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type

Other clearances by Oec-Diasonics, Inc.

  • K926056 — 9600 FLUOROSCOPIC IMAGING SYSTEM (January 21, 1993)
  • K924879 — EP 3000 (January 4, 1993)
  • K914446 — UROVIEW 2000, MODIFICATION (January 10, 1992)
  • K896583 — F.A.S.T. TABLE (March 1, 1990)
  • K893475 — UROVIEW II (August 10, 1989)
  • K864837 — MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM (January 30, 1987)
  • K843972 — ANGIOPLUS-S (January 3, 1985)

Other clearances for product code KQS

  • K955019 — UROTRACT I (December 6, 1995)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K860040 — HYDRAJUST III UROLOGICAL TABLE (February 10, 1986)
  • K852127 — AMSCO URO-ENDO MOBILE TABLE (August 8, 1985)
  • K801723 — UR 150-UR 150T (August 13, 1980)
  • K791699 — HYDRADJUST II UROLOGICAL TABLE (October 22, 1979)
  • K760522 — TABLE, UROSURGICAL (December 16, 1976)

FDA data resources