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510(k) K090895

EKG-PLUS II SOFTWARE by Bionet Co., Ltd. — Product Code LOS

K090895 is an FDA 510(k) premarket notification submitted by Bionet Co., Ltd. for the device "EKG-PLUS II SOFTWARE". The FDA issued a decision of Substantially Equivalent on August 26, 2009. Bionet Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2009
Date Received
March 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Bionet Co., Ltd.

  • K231160 — Cardio Q50, Cardio Q70 (December 15, 2023)
  • K231150 — Cardio P1 (November 9, 2023)
  • K220535 — Cardio10 (November 15, 2022)
  • K220169 — SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10 (October 11, 2022)
  • K130322 — SPM-300 (November 15, 2013)
  • K113306 — CARDIO 7 (July 16, 2012)
  • K102767 — CARDIO XP (June 3, 2011)
  • K082008 — BIONET BM3PLUS PATIENT MONITOR (December 11, 2008)
  • K043597 — FC 700 FETAL MONITOR (December 16, 2005)
  • K043598 — FC 1400 FETAL MONITOR (December 16, 2005)

Other clearances for product code LOS

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

FDA data resources