Cleared Abbreviated

TRIO MONITOR MODEL 0998-00-0600

K032338 · Datascope Corp. · Cardiovascular

Feb 2004

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K032338 is an FDA 510(k) clearance for the TRIO MONITOR MODEL 0998-00-0600, 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 February 11, 2004, 197 days after receiving the submission on July 29, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K032338 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2003
Decision Date	February 11, 2004
Days to Decision	197 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