Cleared Special

TRIO MONITOR

K051897 · Datascope Corp. · Cardiovascular

Aug 2005

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K051897 is an FDA 510(k) clearance for the TRIO MONITOR, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Datascope Corp. (Mahwah, US). The FDA issued a Cleared decision on August 12, 2005, 30 days after receiving the submission on July 13, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K051897 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2005
Decision Date	August 12, 2005
Days to Decision	30 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Statement

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