Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP— 510(k) K181393

Name: FDA 510(k) clearance K181393
Creator: U.S. Food and Drug Administration
Published: 2019-02-15

Substantially Equivalent

Valmed S.R.L.

FDA 510(k) clearance K181393 for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP, Substantially Equivalent on 2019-02-15. Applicant: Valmed S.R.L.. Device class: 2.

Clearance details

Applicant: Valmed S.R.L.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 2018-05-29
Decision date: 2019-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tovo Sant'Agata, IT

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.