510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011328Substantially Equivalent

Cardio Care EKG-2000 12-Channel Electrocardiograph

Bionet Co., Ltd., Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011328 is the FDA 510(k) clearance record for CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH, cleared for Bionet Company, Ltd. on under FDA product code LOS. FDA records list 14 510(k) clearances for Bionet Company, Ltd., from to . As of , FDA records show no recalls naming K011328.

Clearance record

Decision date
Received
(204 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
Bionet Company, Ltd. 3f, Daeyang Bldg., 999, Seoul, KR
510(k) summary
Summary
Third party review
No

Clearances, product code LOS

Trailing 12 months

FDA records hold no clearances under product code LOS in the trailing twelve months.

FDA records show no clearances under product code LOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260