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510(k) K974352

CARDIOVIEW 3000 SOFTWARE by Micromedical, Inc. — Product Code LOS

K974352 is an FDA 510(k) premarket notification submitted by Micromedical, Inc. for the device "CARDIOVIEW 3000 SOFTWARE". The FDA issued a decision of Substantially Equivalent on September 8, 1998. Micromedical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
November 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Micromedical, Inc.

  • K974220 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (August 25, 1998)
  • K974351 — BIOLOG 3000 ELECTROCARDIOGRAPH (April 1, 1998)
  • K970305 — PRINTER INTERFACE (August 15, 1997)
  • K955891 — CARDIOVIEW TRANSTELEPHONIC SOFTWARE (October 8, 1996)
  • K895535 — PACEVIEW (March 19, 1990)
  • K895534 — BIOLOG (March 19, 1990)

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