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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
K201384
510(k) Type
Traditional
Applicant
Shenzhen Raysintone Technology CO., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/7/2020
Days to Decision
195 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
K201384
510(k) Type
Traditional
Applicant
Shenzhen Raysintone Technology CO., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/7/2020
Days to Decision
195 days
Submission Type
Summary