Cleared Abbreviated

TRIO MONITOR

K041907 · Datascope Corp. · Cardiovascular

Jul 2004

Decision

Days

Class 2

Risk

About This 510(k) Submission

K041907 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 July 23, 2004, 8 days after receiving the submission on July 15, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K041907 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2004
Decision Date	July 23, 2004
Days to Decision	8 days
Submission Type	Abbreviated
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