Medical Device Manufacturer · US , San Diego , CA

Aerocrine AB - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2003

Recent clearances: NIOX VERO Airway Inflammation Monitor, NIOX VERO AIRWAY INFLAMMATION MONITOR, NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

6

Total

5

Cleared

1

Denied

FDA 510(k) Regulatory Record - Aerocrine AB Toxicology ✕

1 devices

1-1 of 1

Not Cleared Apr 30, 2003

NIOX ARTICLE NO: 02-1000

DEN030001 · MXA

Toxicology · 43d