K103740

Substantially Equivalent

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE

Applicant: Spectra Medical Devices, Inc.
Product code: NGT
Advisory panel: General Hospital
Date received: 2010-12-22
Decision date: 2011-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Adverse events under product code NGT

product code NGT

Death: 12
Malfunction: 2,008
Other: 4
Total: 2,024

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.