Home / 510(k) Clearances / K960272

510(k) K960272

EAGLE 3000/3100 PATIENT MONITOR by Marquette Electronics, Inc. — Product Code MLD

K960272 is an FDA 510(k) premarket notification submitted by Marquette Electronics, Inc. for the device "EAGLE 3000/3100 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on October 2, 1996. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Marquette Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1996
Date Received
January 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, St Segment With Alarm
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Marquette Electronics, Inc.

  • K971868 — IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM (November 13, 1997)
  • K971683 — WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET (October 22, 1997)
  • K972199 — SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (September 25, 1997)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (February 24, 1997)
  • K964750 — EAGLE 4000 PATIENT MONITOR (February 21, 1997)
  • K962551 — CARDIOSERV S (November 19, 1996)
  • K960418 — EAGLE PATIENT MONITOR (October 2, 1996)
  • K961139 — EAGLE PATIENT MONITOR MODEL 3000/3100 (August 9, 1996)

Other clearances for product code MLD

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (March 13, 2008)
  • K022740 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAR (November 14, 2002)
  • K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (September 14, 2001)
  • K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (December 5, 2000)
  • K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (November 1, 1999)
  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
  • K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS (February 26, 1998)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)

FDA data resources