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

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..

Clearance details

Applicant: Valmed S.R.L.
Product code: Code KPE
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

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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.