Capnia Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2198-2025Class IIPrecision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide MonitorApril 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K151107CoSense ETCO MonitorJuly 22, 2015
K130036COSENSE CO MONITORJanuary 14, 2014
K121768COSENSEOctober 31, 2012