TRENDS LANCET— 510(k) K843882

Name: FDA 510(k) clearance K843882
Creator: U.S. Food and Drug Administration
Published: 1984-11-05

Substantially Equivalent

Orange Medical Instruments, Inc.

FDA 510(k) clearance K843882 for TRENDS LANCET, Substantially Equivalent on 1984-11-05. Applicant: Orange Medical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Orange Medical Instruments, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1984-10-02
Decision date: 1984-11-05
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 KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.