Cleared Traditional

K092027 - CARESCAPE MONITOR B850
(FDA 510(k) Clearance)

K092027 · Ge Medical Systems Information Technologies · Cardiovascular

Aug 2009

Decision

53d

Days

Class 2

Risk

K092027 is an FDA 510(k) clearance for the CARESCAPE MONITOR B850. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX).

Submitted by Ge Medical Systems Information Technologies (Needham, US). The FDA issued a Cleared decision on August 28, 2009, 53 days after receiving the submission on July 6, 2009.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K092027 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2009
Decision Date	August 28, 2009
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1025