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510(k) K843439

CENTURIAN HYDRAULIC STRETCHER by American Sterilizer Co. — Product Code FPO

K843439 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "CENTURIAN HYDRAULIC STRETCHER". The FDA issued a decision of Substantially Equivalent on September 13, 1984. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1984
Date Received
September 4, 1984
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 American Sterilizer Co.

  • K943288 — AMSCO SQ240 SURGICAL LIGHT (October 17, 1994)
  • K931872 — THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER (February 7, 1994)
  • K922485 — CHEMDI-VHP CHEMICAL INDICATOR (September 29, 1993)
  • K930493 — QUANTUM 3080 SURGICAL TABLE (June 22, 1993)
  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K896674 — AMSCO QUANTUM LIGHT (January 3, 1990)
  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K880198 — GEMINI SURGICAL LIGHT (February 10, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)

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