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CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171028
510(k) Type
Traditional
Applicant
GE Healthcare Finland OY
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
8/17/2017
Days to Decision
134 days
Submission Type
Summary

CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171028
510(k) Type
Traditional
Applicant
GE Healthcare Finland OY
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
8/17/2017
Days to Decision
134 days
Submission Type
Summary