510(k) Report

Devices descending from DEN030001

10 later devices reach Niox Article NO: 02-1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072816Niox MinoAerocrine AB20089—
+2K182874Fenom Pro Nitric Oxide TestSpirosure, Inc.201921
+2K101034Niox Mino Model 09-1000Aerocrine AB20105—
+3K213611Fenom ProCaire Diagnostics, Inc.20231—
+3K133898Niox Vero Airway Inflammation MonitorAerocrine AB20143—
+3K123683Niox Panel for Use with the Niox Mino Airway Inflammation MonitorAerocrine AB20120—
+4K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation20250—
+4K150233NIOX VERO Airway Inflammation MonitorAerocrine AB20152—
+5K170983Niox VeroCircassia AB20171—
+6K203695NObreath®Bedfont Scientific, Ltd.20210—