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510(k) K943864

STRYKER 8000 SURGERY STRETCHER by Stryker Medical — Product Code FPO

K943864 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "STRYKER 8000 SURGERY STRETCHER". The FDA issued a decision of Substantially Equivalent on August 25, 1994. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Stryker Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1994
Date Received
August 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled
Device Class
Class II
Regulation Number
880.6910
Review Panel
HO
Submission Type

Other clearances by Stryker Medical

  • K222818 — Xpedition ™ Powered Stair Chair (625700000000) (January 24, 2023)
  • K180834 — Altrix Precision Temperature Management System (August 10, 2018)
  • K171149 — Altrix Temperature Management Wraps (July 18, 2017)
  • K152266 — Altrix Precision Temperature Management System (December 2, 2016)
  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K946149 — STRYKER AGILITY INTENSIVE CARE BED (March 14, 1995)
  • K935949 — STRYKER 5000 (June 17, 1994)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K940068 — STRYKER OPERATING ROOM TABLE (May 5, 1994)
  • K935297 — STRYKER AMBULANCE COT MODEL 6060 (February 18, 1994)

Other clearances for product code FPO

  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K072598 — IRSG I-MOVER FOR BEDS (April 14, 2008)
  • K972528 — DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (July 28, 1997)
  • K955766 — ADULT-PEDIATRIC TRANSPORT SYSTEM (August 7, 1996)
  • K962181 — HARE MODEL 2000 EZ LOADER MODEL 95555 (August 1, 1996)
  • K961437 — WHEELED STRETCHER (June 3, 1996)
  • K952447 — HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (November 22, 1995)
  • K946101 — EMERGENCY/ACCIDENT TROLLEY 550 (February 7, 1995)
  • K945431 — MODEL 792 CONVERGE, MODEL 793 VISION 2000 (January 25, 1995)
  • K943969 — MODEL 578 MOBILE SURGICAL STRETCHER (January 25, 1995)

FDA data resources