PEDIATRIC EXTEN. SET FOR SECOND-DRUG— 510(k) K830198

Name: FDA 510(k) clearance K830198
Creator: U.S. Food and Drug Administration
Published: 1983-02-07

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K830198 for PEDIATRIC EXTEN. SET FOR SECOND-DRUG, Substantially Equivalent on 1983-02-07. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1983-01-20
Decision date: 1983-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.