SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML— 510(k) K113033

Substantially Equivalent

Nephron Pharmaceuticals Corp.

FDA 510(k) clearance K113033 for SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML, Substantially Equivalent on 2012-06-19. Applicant: Nephron Pharmaceuticals Corp..

Clearance details

Applicant: Nephron Pharmaceuticals Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2011-10-12
Decision date: 2012-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.