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510(k) K964750

EAGLE 4000 PATIENT MONITOR by Marquette Electronics, Inc. — Product Code LOS

K964750 is an FDA 510(k) premarket notification submitted by Marquette Electronics, Inc. for the device "EAGLE 4000 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on February 21, 1997. Marquette Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1997
Date Received
November 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K962551 — CARDIOSERV S (November 19, 1996)
  • K960418 — EAGLE PATIENT MONITOR (October 2, 1996)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)
  • K961139 — EAGLE PATIENT MONITOR MODEL 3000/3100 (August 9, 1996)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)

FDA data resources