Cleared Special

BEDSIDE MONITOR, MODEL OPV-1500

K032749 · Nihon Kohden America, Inc. · Cardiovascular

Sep 2003

Decision

11d

Days

Class 2

Risk

About This 510(k) Submission

K032749 is an FDA 510(k) clearance for the BEDSIDE MONITOR, MODEL OPV-1500, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on September 16, 2003, 11 days after receiving the submission on September 5, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K032749 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2003
Decision Date	September 16, 2003
Days to Decision	11 days
Submission Type	Special
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