Cleared Special

K102426 - CARESCAPE MODEL V100 VITAL SIGNS MONITOR (FDA 510(k) Clearance)

K102426 · Ge Medical Systems Information Technologies · Cardiovascular device

Oct 2010

Decision

56d

Days

Class 2

Risk

K102426 is an FDA 510(k) clearance for the CARESCAPE MODEL V100 VITAL SIGNS 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 (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 FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K102426 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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