ZOLL CODE WRITER— 510(k) K132488

Clearance details

Applicant

ZOLL Medical Corporation

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2013-08-08

Decision date

2014-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chelsmford, MA, US

• K212003 — ESSENZ Patient Monitor2021-11-10
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• K201162 — Essence 55SP Large Monitor System2020-08-27
• K173107 — Vios Central Station Monitor Software, Vios Central Server Software2018-07-26
• K180534 — Philips IntelliVue GuardianSoftware2018-07-16

• K233486 — 731 Series Ventilator2024-12-13
• K202375 — ZOLL Propaq M2021-03-09
• K180482 — ZOLL Propaq M2018-11-30
• K172653 — Power Infuser2018-07-18
• 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 →