NOX MEDICAL

FDA Regulatory Profile

NOX MEDICAL appears in FDA public data with 1 recall, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0031-2022, Class II) was initiated on September 7, 2021. Its most recent 510(k) clearance was granted on November 13, 2019.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0031-2022Class IINox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during September 7, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K192469Nox Sleep SystemNovember 13, 2019
K124062QDC-PRO, AND NOX-RIPJuly 10, 2013
K082113NOX T3, NOXTURNAL (PC APPLICATION)November 7, 2008