Cleared Traditional

K014255 - DINAMAP PROCARE SERIES MONITOR (FDA 510(k) Clearance)

Also includes:

MODEL 100, 200, 300, 400

K014255 · Ge Medical Systems Information Technologies · Cardiovascular device

Jul 2002

Decision

188d

Days

Class 2

Risk

K014255 is an FDA 510(k) clearance for the DINAMAP PROCARE SERIES MONITOR. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Ge Medical Systems Information Technologies (Tampa, US). The FDA issued a Cleared decision on July 2, 2002, 188 days after receiving the submission on December 26, 2001.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K014255 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 26, 2001
Decision Date	July 02, 2002
Days to Decision	188 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