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510(k) K840920

KEYMED MOBILE ENDOSCOPY PATIENT COUCH by Keymed, Inc. — Product Code FPO

K840920 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "KEYMED MOBILE ENDOSCOPY PATIENT COUCH". The FDA issued a decision of Substantially Equivalent on Mar 19, 1984. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Keymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 19, 1984
Date Received
Mar 1, 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 Keymed, Inc.

  • K100803 — OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (Apr 22, 2010)
  • K921179 — OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 (Mar 29, 1993)
  • K881004 — OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR (May 12, 1988)
  • K861821 — KEYMED FIBERSCOPE AUTO DISINFECTOR (Feb 12, 1987)
  • K864801 — THE KEYMED HI-LIGHT 250 LIGHT SOURCE (Dec 24, 1986)
  • K862000 — KEYMED FLEXIBLE ESOPHAGEAL DILATORS (Aug 12, 1986)
  • K860528 — THE KEYMED FIBERSCOPE STERILIZATION CASE (Jul 15, 1986)
  • K861147 — UCS-2, ULTRASONIC CLEANING SOLUTION (Jun 23, 1986)
  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (Jun 17, 1986)
  • K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (Nov 26, 1985)

Other clearances for product code FPO

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

FDA data resources