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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 Jan 6, 1978. Intl. Business Machines has at least 7 other 510(k) clearances on record.

Clearance Details

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

Other clearances by Intl. Business Machines

  • K831004 — AUTOMATED 8400 BLOOD CELL SEPARATOR (Sep 12, 1983)
  • K830163 — IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS (Feb 18, 1983)
  • K812355 — IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 (Sep 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 (Sep 6, 1977)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (Jan 10, 1977)

Other clearances for product code LOS

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

FDA data resources