Last synced on 14 November 2025 at 11:06 pm

EM Provisional

Page Type
Cleared 510(K)
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)
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