Xhale Assurance, Inc.

FDA Regulatory Profile

Xhale Assurance, Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2133-2019, Class II) was initiated on May 8, 2019.

Summary

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

Recent Recalls

NumberClassProductDate
Z-2133-2019Class IINasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ NasalMay 8, 2019