ZOLL RESCUENET EPCR MODEL RESCUENET EPCR— 510(k) K103473

Clearance details

Applicant

ZOLL Medical Corporation

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2010-11-24

Decision date

2011-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chelsmford, MA, US

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• K162832 — 731 Series Ventilators2017-08-02

Death

2

Total

2

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 →