Last synced on 27 January 2023 at 11:04 pm

InPen System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192841
510(k) Type
Traditional
Applicant
Companion Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/10/2020
Days to Decision
130 days
Submission Type
Summary

InPen System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192841
510(k) Type
Traditional
Applicant
Companion Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/10/2020
Days to Decision
130 days
Submission Type
Summary