FPP IV SECURE— 510(k) K840683

Name: FDA 510(k) clearance K840683
Creator: U.S. Food and Drug Administration
Published: 1984-03-06

Substantially Equivalent

Fpp, Inc.

FDA 510(k) clearance K840683 for FPP IV SECURE, Substantially Equivalent on 1984-03-06. Applicant: Fpp, Inc.. Device class: 1.

Clearance details

Applicant: Fpp, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1984-02-15
Decision date: 1984-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K840684 — FPP ARMBOARD STRAP1984-04-23

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.