Last synced on 23 September 2022 at 11:05 pm

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