FLEXIFLO COMPANION ENTERAL NUTRITION PUMP— 510(k) K873119

Substantially Equivalent

Frantz Medical Development, Ltd.

FDA 510(k) clearance K873119 for FLEXIFLO COMPANION ENTERAL NUTRITION PUMP, Substantially Equivalent on 1987-11-05. Applicant: Frantz Medical Development, Ltd..

Clearance details

Applicant
Frantz Medical Development, Ltd.
Product code
Code LZH
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, 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.