ZOLL Propaq M— 510(k) K202375

Name: FDA 510(k) clearance K202375
Creator: U.S. Food and Drug Administration
Published: 2021-03-09

Substantially Equivalent

ZOLL Medical Corporation

FDA 510(k) clearance K202375 for ZOLL Propaq M, Substantially Equivalent on 2021-03-09. Applicant: ZOLL Medical Corporation. Device class: 2.

Clearance details

Applicant: ZOLL Medical Corporation
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2020-08-20
Decision date: 2021-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsmford, MA, US

Download summary PDF View on FDA.gov ↗

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from ZOLL Medical Corporation

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K233486 — 731 Series Ventilator2024-12-13
K180482 — ZOLL Propaq M2018-11-30
K172653 — Power Infuser2018-07-18
K162832 — 731 Series Ventilators2017-08-02
K170533 — Model 330 Multifunction Aspirator2017-04-18

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.