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510(k) K932186

BYPASS LEG POSITIONER by Voss Medical Products — Product Code FQO

K932186 is an FDA 510(k) premarket notification submitted by Voss Medical Products for the device "BYPASS LEG POSITIONER". The FDA issued a decision of Substantially Equivalent on June 1, 1993. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Voss Medical Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1993
Date Received
May 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Voss Medical Products

  • K932187 — PRONE POSITIONER (June 1, 1993)
  • K896338 — VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA (May 17, 1990)
  • K885161 — VOSS VEIN CLAMP (December 22, 1989)
  • K895369 — VOSS GRAFT MARKER (September 27, 1989)

Other clearances for product code FQO

  • K240598 — Maestro System (REF100) (June 3, 2024)
  • K221410 — Maestro Platform (December 2, 2022)
  • K090136 — STERIS CMAX XLT SURGICAL TABLE (March 20, 2009)
  • K972810 — OPT80 THE TRANSPORTABLE (OPT80) (August 26, 1997)
  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K971307 — AMSCO SURGICAL TABLE (June 27, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K955750 — TELETOM (February 8, 1996)

FDA data resources