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510(k) K863083

BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER by Beta Medical Products Co. — Product Code FPO

K863083 is an FDA 510(k) premarket notification submitted by Beta Medical Products Co. for the device "BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER". The FDA issued a decision of Substantially Equivalent on September 3, 1986. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Beta Medical Products Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1986
Date Received
August 12, 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 Beta Medical Products Co.

  • K954278 — BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 (October 2, 1995)
  • K884531 — BETA 90/50 MOBILE IMAGING TABLE (January 11, 1989)

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