MONITOR, PORTABLE, PART #431-010— 510(k) K770279

Clearance details

Applicant

Mennen Greatbatch Electonics

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

1977-02-14

Decision date

1977-02-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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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

• K772000 — ECG TELEMETRY SYSTEM1977-11-22
• K770832 — PORTASCOPE II1977-06-03
• K770245 — ABDOMINAL FETAL ECG MODULE1977-02-14
• K770246 — ISOLATED EEG AMPLIFIER MODULE1977-02-14
• K770247 — D.C. AMPLIFIER MODULE1977-02-14

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 →