510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090895Substantially Equivalent

EKG-Plus II Software

Bionet Co., Ltd., -Gu, Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090895 is the FDA 510(k) clearance record for EKG-PLUS II SOFTWARE, cleared for Bionet Co., Ltd. on under FDA product code LOS. FDA records list 14 510(k) clearances for Bionet Co., Ltd., from to . As of , FDA records show no recalls naming K090895.

Clearance record

Decision date
Received
(149 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
Bionet Co., Ltd. Rm. 431, Lifeofficetel, -Gu, Seoul, KR
510(k) summary
Summary PDF
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