COMPAT ENTERAL DELIVERY PUMP SETS— 510(k) K140947

Substantially Equivalent

Nestle Healthcare Nutrition, Inc.

FDA 510(k) clearance K140947 for COMPAT ENTERAL DELIVERY PUMP SETS, Substantially Equivalent on 2014-09-04. Applicant: Nestle Healthcare Nutrition, Inc..

Clearance details

Applicant
Nestle Healthcare Nutrition, Inc.
Product code
Code PIF
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code PIF

product code PIF
Death
13
Injury
122
Other
1
Total
136

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.