TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET— 510(k) K001461

Substantially Equivalent

Biometrix , Ltd.

FDA 510(k) clearance K001461 for TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET, Substantially Equivalent on 2000-09-11. Applicant: Biometrix , Ltd..

Clearance details

Applicant: Biometrix , Ltd.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 2000-05-10
Decision date: 2000-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

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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.