Last synced on 25 January 2026 at 3:41 am

EM Provisional

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191751
510(k) Type
Abbreviated
Applicant
Hiossen, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/2019
Days to Decision
168 days
Submission Type
Summary

EM Provisional

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191751
510(k) Type
Abbreviated
Applicant
Hiossen, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/2019
Days to Decision
168 days
Submission Type
Summary