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510(k) K935123

SUPERSTAND 300 by Wuestec Medical, Inc. — Product Code IYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1996
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type

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  • K981880 — DX-480, ADD ON DIGITAL IMAGER (October 20, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K955414 — XRT 400 (July 24, 1996)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)

Other clearances for product code IYB

  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K940442 — MPR-814 (June 9, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)
  • K914944 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 2, 1991)