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510(k) K903395

UROMAT 2000 by Pausch Corp. — Product Code IXR

K903395 is an FDA 510(k) premarket notification submitted by Pausch Corp. for the device "UROMAT 2000". The FDA issued a decision of Substantially Equivalent on August 30, 1990. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Pausch Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1990
Date Received
July 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Pausch Corp.

  • K081073 — HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F (December 5, 2008)
  • K973864 — COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO (June 17, 1998)
  • K973834 — CS2000 & CS2000 TOMO (April 30, 1998)
  • K870856 — COSMOS (March 30, 1987)
  • K790741 — COMPACT SYSTEM (April 26, 1979)
  • K790742 — KS-78 VERTICAL WALL CASSETTE HOLDER (April 26, 1979)
  • K790740 — BS 66, UNIVERSAL BUCKY STAND (April 26, 1979)
  • K790743 — COORDINATUS, HORIZONTAL RADIOGRAPHOC (April 23, 1979)

Other clearances for product code IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (April 28, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (March 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (September 26, 1995)

FDA data resources