Last synced on 7 June 2024 at 11:04 pm

oCare Wrist Pulse Oximeter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183556
510(k) Type
Traditional
Applicant
Taiwan Biophotonic Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
2/15/2019
Days to Decision
57 days
Submission Type
Summary

oCare Wrist Pulse Oximeter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183556
510(k) Type
Traditional
Applicant
Taiwan Biophotonic Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
2/15/2019
Days to Decision
57 days
Submission Type
Summary