S&W TYPE 888 ELECTRODE— 510(k) K861158

Name: FDA 510(k) clearance K861158
Creator: U.S. Food and Drug Administration
Published: 1986-07-01

Substantially Equivalent

National Medical Technology

FDA 510(k) clearance K861158 for S&W TYPE 888 ELECTRODE, Substantially Equivalent on 1986-07-01. Applicant: National Medical Technology. Device class: 2.

Clearance details

Applicant: National Medical Technology
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1986-03-28
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.