FDA.reportPublic FDA data

Device Listing 1267447659

Listing Summary#

Listing key
1267447659
Premarket submission
K183394
Device
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
Applicant
GE Healthcare Finland Oy
Product code
CCK
Decision date
2019-05-01