510(k) K110516

CONNEX VITAL SIGNS MONITOR 6000 SERIES by Welch Allyn, Inc. — Product Code MWI

K110516 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "CONNEX VITAL SIGNS MONITOR 6000 SERIES". The FDA issued a decision of Substantially Equivalent on June 1, 2011. 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
June 1, 2011
Date Received
February 23, 2011
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