Cleared Special

CARESCAPE MODEL V100 VITAL SIGNS MONITOR

K102426 · Ge Medical Systems Information Technologies · Cardiovascular

Oct 2010

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K102426 is an FDA 510(k) clearance for the CARESCAPE MODEL V100 VITAL SIGNS MONITOR, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on October 20, 2010, 56 days after receiving the submission on August 25, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K102426 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2010
Decision Date	October 20, 2010
Days to Decision	56 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