Home / 510(k) Clearances / K953980

510(k) K953980

KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT by Kreuzer Corp. — Product Code FQO

K953980 is an FDA 510(k) premarket notification submitted by Kreuzer Corp. for the device "KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT". The FDA issued a decision of Substantially Equivalent on November 16, 1995. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1995
Date Received
August 23, 1995
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 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