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510(k) K915327

ELITE II ELECTROCARDIOGRAPH,MODIFIED by Siemens Burdick, Inc. — Product Code LOS

K915327 is an FDA 510(k) premarket notification submitted by Siemens Burdick, Inc. for the device "ELITE II ELECTROCARDIOGRAPH,MODIFIED". The FDA issued a decision of Substantially Equivalent on October 9, 1992. Siemens Burdick, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1992
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Siemens Burdick, Inc.

  • K915225 — MEGACART (July 1, 1992)
  • K915202 — INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH (May 15, 1992)
  • K914969 — E350I ELECTROCARDIOGRAPH (March 26, 1992)
  • K913518 — TA620 TREADMILL CONTROLLER (October 24, 1991)
  • K910634 — DC200 DEFIBRILLATOR (July 24, 1991)
  • K910867 — T600 TREADMILL (May 31, 1991)

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