EKG-PLUS II SOFTWARE— 510(k) K090895

Substantially Equivalent

Bionet Co., Ltd.

FDA 510(k) clearance K090895 for EKG-PLUS II SOFTWARE, Substantially Equivalent on 2009-08-26. Applicant: Bionet Co., Ltd..

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code LOS
Advisory panel: Unknown
Date received: 2009-03-30
Decision date: 2009-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: -Gu, Seoul, KR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.