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Reusable SpO2 Sensor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191420
510(k) Type
Traditional
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/11/2019
Days to Decision
136 days
Submission Type
Summary

Reusable SpO2 Sensor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191420
510(k) Type
Traditional
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/11/2019
Days to Decision
136 days
Submission Type
Summary