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510(k) K926463

RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES by Midmark Corp. — Product Code FQO

K926463 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES". The FDA issued a decision of Substantially Equivalent on October 21, 1994. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1994
Date Received
December 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
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 FQO

  • K240598 — Maestro System (REF100) (June 3, 2024)
  • K221410 — Maestro Platform (December 2, 2022)
  • K090136 — STERIS CMAX XLT SURGICAL TABLE (March 20, 2009)
  • K972810 — OPT80 THE TRANSPORTABLE (OPT80) (August 26, 1997)
  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K971307 — AMSCO SURGICAL TABLE (June 27, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K955750 — TELETOM (February 8, 1996)

FDA data resources