510(k) K241958

WARD-CSS (v1.2.x) by Ward 24/7 Aps — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2025
Date Received
July 3, 2024
Clearance Type
Traditional
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