ROSS EMBRACE ENTERAL PUMP— 510(k) K031407

Substantially Equivalent

Ross Product Div. Abbott Laboratories

FDA 510(k) clearance K031407 for ROSS EMBRACE ENTERAL PUMP, Substantially Equivalent on 2003-05-20. Applicant: Ross Product Div. Abbott Laboratories.

Clearance details

Applicant: Ross Product Div. Abbott Laboratories
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2003-05-05
Decision date: 2003-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

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.