510(k) K202375

ZOLL Propaq M by ZOLL Medical Corporation — Product Code MWI

K202375 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL Propaq M". The FDA issued a decision of Substantially Equivalent on March 9, 2021. 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. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2021
Date Received
August 20, 2020
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