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510(k) K963506

TENET RADIOLUCENT HAND TABLE by Tenet Medical Engineering — Product Code FQO

K963506 is an FDA 510(k) premarket notification submitted by Tenet Medical Engineering for the device "TENET RADIOLUCENT HAND TABLE". The FDA issued a decision of Substantially Equivalent on January 9, 1997. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Tenet Medical Engineering has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1997
Date Received
September 3, 1996
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 Tenet Medical Engineering

  • K963505 — TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM (February 14, 1997)
  • K964102 — TENET TIBIAL FRACTURE SUPPORT (December 5, 1996)

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)
  • 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)
  • K953980 — KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT (November 16, 1995)

FDA data resources