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XactTrace Single Use Respiratory Effort Belt System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173793
510(k) Type
Traditional
Applicant
Embla Systems
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/1/2019
Days to Decision
442 days
Submission Type
Summary

XactTrace Single Use Respiratory Effort Belt System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173793
510(k) Type
Traditional
Applicant
Embla Systems
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/1/2019
Days to Decision
442 days
Submission Type
Summary