Normal Saline Flush— 510(k) K150143

Substantially Equivalent

Nurse Assist, Inc.

FDA 510(k) clearance K150143 for Normal Saline Flush, Substantially Equivalent on 2015-08-31. Applicant: Nurse Assist, Inc..

Clearance details

Applicant
Nurse Assist, Inc.
Product code
Code NGT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Haltom City, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NGT

product code NGT
Death
12
Malfunction
2,008
Other
4
Total
2,024

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.