FLUOROSCAN NEONATAL— 510(k) K950415

Name: FDA 510(k) clearance K950415
Creator: U.S. Food and Drug Administration
Published: 1995-09-05

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K950415 for FLUOROSCAN NEONATAL, Substantially Equivalent on 1995-09-05. Applicant: Isolab, Inc.. Device class: 1.

Clearance details

Applicant: Isolab, Inc.
Product code: Code KHO
Device class: Class 1
Regulation: 21 CFR 862.2560
Advisory panel: Clinical Chemistry
Date received: 1995-01-31
Decision date: 1995-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.