Last synced on 2 December 2022 at 11:04 pm

SmartBag (SmartPouch)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181643
510(k) Type
Traditional
Applicant
11 Health Technologies Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/16/2018
Days to Decision
147 days
Submission Type
Summary

SmartBag (SmartPouch)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181643
510(k) Type
Traditional
Applicant
11 Health Technologies Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/16/2018
Days to Decision
147 days
Submission Type
Summary