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510(k) K962181

HARE MODEL 2000 EZ LOADER MODEL 95555 by Dyna Corp. — Product Code FPO

K962181 is an FDA 510(k) premarket notification submitted by Dyna Corp. for the device "HARE MODEL 2000 EZ LOADER MODEL 95555". The FDA issued a decision of Substantially Equivalent on August 1, 1996. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Dyna Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1996
Date Received
June 6, 1996
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 Dyna Corp.

  • K972528 — DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (July 28, 1997)
  • K902503 — HARE FOLDING BACK EMERGENCY STRETCHER (June 26, 1990)
  • K900670 — HARE EMERGENCY STRETCHER (April 23, 1990)
  • K900671 — HARE EMERGENCY STRETCHER WITH WHEELS (April 23, 1990)

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)
  • K961437 — WHEELED STRETCHER (June 3, 1996)
  • K952447 — HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (November 22, 1995)
  • K946101 — EMERGENCY/ACCIDENT TROLLEY 550 (February 7, 1995)
  • K943969 — MODEL 578 MOBILE SURGICAL STRETCHER (January 25, 1995)
  • K945431 — MODEL 792 CONVERGE, MODEL 793 VISION 2000 (January 25, 1995)
  • K942948 — STRYKER POWERED STRETCHER (January 24, 1995)

FDA data resources