Last synced on 12 July 2024 at 11:04 pm

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211171
510(k) Type
Traditional
Applicant
GE Healthcare Finland Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
10/21/2021
Days to Decision
185 days
Submission Type
Summary

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211171
510(k) Type
Traditional
Applicant
GE Healthcare Finland Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
10/21/2021
Days to Decision
185 days
Submission Type
Summary