Cleared Special

K021435 - DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N (FDA 510(k) Clearance)

K021435 · Ge Medical Systems Information Technologies · Cardiovascular device

May 2002

Decision

16d

Days

Class 2

Risk

K021435 is an FDA 510(k) clearance for the DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N. 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 May 22, 2002, 16 days after receiving the submission on May 6, 2002.

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

Submission Details

510(k) Number	K021435 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 06, 2002
Decision Date	May 22, 2002
Days to Decision	16 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