Last synced on 27 January 2023 at 11:04 pm

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211632
510(k) Type
Traditional
Applicant
Shenzhen Narig Bio-Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/14/2022
Days to Decision
232 days
Submission Type
Summary

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211632
510(k) Type
Traditional
Applicant
Shenzhen Narig Bio-Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/14/2022
Days to Decision
232 days
Submission Type
Summary