Last synced on 6 December 2024 at 11:05 pm

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232520
510(k) Type
Traditional
Applicant
Shenzhen Smallsignal Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/21/2024
Days to Decision
461 days
Submission Type
Summary

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232520
510(k) Type
Traditional
Applicant
Shenzhen Smallsignal Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/21/2024
Days to Decision
461 days
Submission Type
Summary