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510(k) K011328

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH by Bionet Company, Ltd. — Product Code LOS

K011328 is an FDA 510(k) premarket notification submitted by Bionet Company, Ltd. for the device "CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on November 21, 2001. Bionet Company, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2001
Date Received
May 1, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Bionet Company, Ltd.

  • K023082 — BABYCARE (March 3, 2003)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)

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)
  • 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)
  • K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (April 15, 1999)

FDA data resources