510(k) K132807

MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) by Welch Allyn, Inc. — Product Code MWI

K132807 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)". The FDA issued a decision of Substantially Equivalent on January 31, 2014. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2014
Date Received
September 9, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type