Cleared Traditional

BIONET BM3PLUS PATIENT MONITOR

K082008 · Bionet Co., Ltd. · Cardiovascular

Dec 2008

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K082008 is an FDA 510(k) clearance for the BIONET BM3PLUS PATIENT MONITOR, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Bionet Co., Ltd. (San Marino, US). The FDA issued a Cleared decision on December 11, 2008, 149 days after receiving the submission on July 15, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K082008 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2008
Decision Date	December 11, 2008
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300