I.V. STRIP— 510(k) K792049

Name: FDA 510(k) clearance K792049
Creator: U.S. Food and Drug Administration
Published: 1979-11-20

Substantially Equivalent

E-Med Corp.

FDA 510(k) clearance K792049 for I.V. STRIP, Substantially Equivalent on 1979-11-20. Applicant: E-Med Corp.. Device class: 1.

Clearance details

Applicant: E-Med Corp.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1979-10-12
Decision date: 1979-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.