Cleared Traditional

ZOLL Propaq M

K202375 · ZOLL Medical Corporation · Cardiovascular

Mar 2021

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K202375 is an FDA 510(k) clearance for the ZOLL Propaq M, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on March 9, 2021, 201 days after receiving the submission on August 20, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K202375 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2020
Decision Date	March 09, 2021
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300