510(k) K101619

WELCH ALLYN 1500 PATIENT MONITOR by Schiller AG — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2010
Date Received
June 9, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type