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Pulse Oximeter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203854
510(k) Type
Traditional
Applicant
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/23/2021
Days to Decision
113 days
Submission Type
Summary

Pulse Oximeter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203854
510(k) Type
Traditional
Applicant
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/23/2021
Days to Decision
113 days
Submission Type
Summary