MODEL ECG100 SIMULATOR— 510(k) K897029

Name: FDA 510(k) clearance K897029
Creator: U.S. Food and Drug Administration
Published: 1990-04-26

Substantially Equivalent

Dynatech/Nevada, Inc.

FDA 510(k) clearance K897029 for MODEL ECG100 SIMULATOR, Substantially Equivalent on 1990-04-26. Applicant: Dynatech/Nevada, Inc.. Device class: 2.

Clearance details

Applicant: Dynatech/Nevada, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1989-12-18
Decision date: 1990-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson City, NV, US

Download summary PDF View on FDA.gov ↗

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K934254 — IMPULSE 3000 DEFIBRILLATOR ANALYZER1993-11-23
K897074 — MODEL 215M PATIENT SIMULATOR1990-05-17
K897096 — MODEL 404A I.V. INFUSION PUMP ANALYZER1990-03-15

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.