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510(k) K990266

MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE by Micromedical Industries, Ltd. — Product Code LOS

K990266 is an FDA 510(k) premarket notification submitted by Micromedical Industries, Ltd. for the device "MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE". The FDA issued a decision of Substantially Equivalent on February 2, 1999. Micromedical Industries, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1999
Date Received
January 28, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Other clearances by Micromedical Industries, Ltd.

  • K013311 — MODIFICATION TO: POCKETVIEW ECG SOFTWARE (January 3, 2002)
  • K012540 — BLY-501 ADAPTOR (September 26, 2001)
  • K922528 — CMS SYSTEM (May 12, 1995)
  • K915627 — PACEVIEW (March 27, 1992)
  • K915624 — MODIFIED BIOLOG (March 27, 1992)

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