ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.— 510(k) K911990

Name: FDA 510(k) clearance K911990
Creator: U.S. Food and Drug Administration
Published: 1991-06-21

Substantially Equivalent

Somnitec, Inc.

FDA 510(k) clearance K911990 for ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT., Substantially Equivalent on 1991-06-21. Applicant: Somnitec, Inc.. Device class: 2.

Clearance details

Applicant: Somnitec, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1991-05-06
Decision date: 1991-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.