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510(k) K915073

MARQUETTE SV O2 MODULE by Marquette Electronics, Inc. — Product Code DQE

K915073 is an FDA 510(k) premarket notification submitted by Marquette Electronics, Inc. for the device "MARQUETTE SV O2 MODULE". The FDA issued a decision of Substantially Equivalent on Dec 29, 1992. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Marquette Electronics, Inc. has 81 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 29, 1992
Date Received
Nov 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Oximeter, Fiber-Optic
Device Class
Class II
Regulation Number
870.1230
Review Panel
CV
Submission Type
510(k)

Other clearances by Marquette Electronics, Inc.

  • K971868 — IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM (Nov 13, 1997)
  • K971683 — WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET (Oct 22, 1997)
  • K972199 — SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (Sep 25, 1997)
  • K962547 — CARDIOSERV P (Mar 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (Feb 28, 1997)
  • K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (Feb 24, 1997)
  • K964750 — EAGLE 4000 PATIENT MONITOR (Feb 21, 1997)
  • K962551 — CARDIOSERV S (Nov 19, 1996)
  • K960418 — EAGLE PATIENT MONITOR (Oct 2, 1996)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (Oct 2, 1996)

Other clearances for product code DQE

  • K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry… (Feb 20, 2018)
  • K160645 — PreSep Oligon Oximetry Catheter (Jun 16, 2016)
  • K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY… (Jul 2, 2014)
  • K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (Feb 18, 2011)
  • K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (Sep 18, 2009)
  • K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (Nov 3, 2006)
  • K061585 — OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (Oct 5, 2006)
  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE… (Aug 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (Jun 26, 2006)
  • K060093 — PRESEP OLIGON OXIMETRY CATHETERS (Apr 28, 2006)

FDA data resources