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SedLine Sedation Monitor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172890
510(k) Type
Traditional
Applicant
Masimo Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/26/2018
Days to Decision
126 days
Submission Type
Summary

SedLine Sedation Monitor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172890
510(k) Type
Traditional
Applicant
Masimo Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/26/2018
Days to Decision
126 days
Submission Type
Summary