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Low-frequency Stimulator (Model: AST-645, AST-646)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212989
510(k) Type
Traditional
Applicant
Shenzhen OSTO Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/22/2021
Days to Decision
63 days
Submission Type
Summary

Low-frequency Stimulator (Model: AST-645, AST-646)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212989
510(k) Type
Traditional
Applicant
Shenzhen OSTO Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/22/2021
Days to Decision
63 days
Submission Type
Summary