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Disposable SpO2 Sensors, Reusable SpO2 Sensors

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181270
510(k) Type
Traditional
Applicant
Orantech Inc.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/7/2018
Days to Decision
116 days
Submission Type
Summary

Disposable SpO2 Sensors, Reusable SpO2 Sensors

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181270
510(k) Type
Traditional
Applicant
Orantech Inc.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/7/2018
Days to Decision
116 days
Submission Type
Summary