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510(k) K772353

EKG ACQUISITION & ANALYSIS CART by Intl. Business Machines — Product Code LOS

K772353 is an FDA 510(k) premarket notification submitted by Intl. Business Machines for the device "EKG ACQUISITION & ANALYSIS CART". The FDA issued a decision of Substantially Equivalent on January 6, 1978. Intl. Business Machines has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1978
Date Received
December 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Intl. Business Machines

  • K831004 — AUTOMATED 8400 BLOOD CELL SEPARATOR (September 12, 1983)
  • K830163 — IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS (February 18, 1983)
  • K812355 — IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 (September 9, 1981)
  • K810988 — IBM 5885 DIGITAL ECG ACQUISITION CART (May 1, 1981)
  • K810989 — IBM 5880 ACQUISITION & ANALYSIS CART TEL (May 1, 1981)
  • K771258 — BLOOD CELL SEPARATOR 2997 (September 6, 1977)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)

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