ELECTROCARDIOGRAPH-ECG CALIPER— 510(k) K850021

Name: FDA 510(k) clearance K850021
Creator: U.S. Food and Drug Administration
Published: 1985-02-08

Substantially Equivalent

Devcom, Inc.

FDA 510(k) clearance K850021 for ELECTROCARDIOGRAPH-ECG CALIPER, Substantially Equivalent on 1985-02-08. Applicant: Devcom, Inc.. Device class: 2.

Clearance details

Applicant: Devcom, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1985-01-03
Decision date: 1985-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K861264 — JOINT MEASUREMENT INDICATOR1986-04-15
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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.