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Pulse Oximeter (Model C101A2, C101B1, C101A3)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221979
510(k) Type
Special
Applicant
Shenzhen IMDK Medical Technology CO., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/16/2022
Days to Decision
103 days
Submission Type
Summary

Pulse Oximeter (Model C101A2, C101B1, C101A3)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221979
510(k) Type
Special
Applicant
Shenzhen IMDK Medical Technology CO., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/16/2022
Days to Decision
103 days
Submission Type
Summary