CAIRE DIAGNOSTICS INC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1284-2021Class IICAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device toFebruary 26, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K213611Fenom ProJune 7, 2023