CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES— 510(k) K945034

Name: FDA 510(k) clearance K945034
Creator: U.S. Food and Drug Administration
Published: 1994-10-27

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K945034 for CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES, Substantially Equivalent on 1994-10-27. Applicant: Conmedcorp. Device class: 2.

Clearance details

Applicant: Conmedcorp
Product code: Product code DSA
Device class: Class 2
Regulation: 21 CFR 870.2900
Advisory panel: Cardiovascular
Date received: 1994-10-13
Decision date: 1994-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSA

product code DSA

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.