Cleared Special

SPACELABS MEDICAL PATIENT MONITORS

K102422 · Spacelabs Medical, Inc. · Cardiovascular
Dec 2010
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K102422 is an FDA 510(k) clearance for the SPACELABS MEDICAL PATIENT MONITORS, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on December 7, 2010, 104 days after receiving the submission on August 25, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K102422 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2010
Decision Date December 07, 2010
Days to Decision 104 days
Submission Type Special
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

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