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510(k) K904011

MODEL #527 OPHTHALMIC STRETCHER by Midmark Corp. — Product Code FPO

K904011 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MODEL #527 OPHTHALMIC STRETCHER". The FDA issued a decision of Substantially Equivalent on October 3, 1990. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1990
Date Received
August 29, 1990
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 Midmark Corp.

  • K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100C (January 7, 2013)
  • K120239 — ELEVANCE (August 24, 2012)
  • K112380 — CLEARVISION (November 22, 2011)
  • K091866 — PROGENY VANTAGE PANORAMIC X-RAY SYSTEM (July 20, 2009)
  • K090670 — MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER (July 7, 2009)
  • K023348 — MIDMARK M9 ULTRACLAVE STEAM STERILIZER (March 3, 2003)
  • K003090 — MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (October 18, 2000)
  • K992744 — MIDMARK M4*9 EASYCLAVE STEAM STERILIZER (January 10, 2000)
  • K990189 — MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (April 19, 1999)
  • K936181 — MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (November 30, 1994)

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