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Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180001
510(k) Type
Abbreviated
Applicant
Embla Systems
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
9/27/2019
Days to Decision
633 days
Submission Type
Summary

Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180001
510(k) Type
Abbreviated
Applicant
Embla Systems
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
9/27/2019
Days to Decision
633 days
Submission Type
Summary