FLEXIFLO 6.1 ENTERAL NUTRITION PUMP— 510(k) K951429

Substantially Equivalent - Subject to Tracking Reg.

Ross Products

FDA 510(k) clearance K951429 for FLEXIFLO 6.1 ENTERAL NUTRITION PUMP, Substantially Equivalent - Subject to Tracking Reg. on 1995-12-22. Applicant: Ross Products.

Clearance details

Applicant
Ross Products
Product code
Code LZH
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent - Subject to Tracking Reg.
Clearance type
Traditional
Location
Columbus, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZH

product code LZH
Death
12
Malfunction
4,186
Total
4,198

Source: openFDA MAUDE database, through . 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.