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510(k) K864269

MODEL 35-B ALL LEVEL COT by Ferno-Washington, Inc. — Product Code FPO

K864269 is an FDA 510(k) premarket notification submitted by Ferno-Washington, Inc. for the device "MODEL 35-B ALL LEVEL COT". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Ferno-Washington, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1986
Date Received
October 29, 1986
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 Ferno-Washington, Inc.

  • K980033 — FERNO HEALTHCARE RECLINE-A-BATH 2 (April 21, 1998)
  • K932417 — FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT (September 9, 1993)
  • K864765 — MODEL 668, TRACTION SPLINT, ADULT (December 17, 1986)
  • K862441 — EZ LOAD MODEL 30, ALL LEVEL COT (September 12, 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