Cleared Traditional

Bioflux Software II

K201040 · Biotricity · Cardiovascular

Jul 2020

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K201040 is an FDA 510(k) clearance for the Bioflux Software II, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Biotricity (Redwood City, US). The FDA issued a Cleared decision on July 29, 2020, 119 days after receiving the submission on April 1, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K201040 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2020
Decision Date	July 29, 2020
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF