VARIOUSPATIENT MONITORING CABLE— 510(k) K942321

Name: FDA 510(k) clearance K942321
Creator: U.S. Food and Drug Administration
Published: 1994-11-04

Substantially Equivalent

Merit Cables Incorporated

FDA 510(k) clearance K942321 for VARIOUSPATIENT MONITORING CABLE, Substantially Equivalent on 1994-11-04. Applicant: Merit Cables Incorporated. Device class: 2.

Clearance details

Applicant: Merit Cables Incorporated
Product code: Product code DSA
Device class: Class 2
Regulation: 21 CFR 870.2900
Advisory panel: Cardiovascular
Date received: 1994-05-13
Decision date: 1994-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, 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.