Last synced on 10 January 2025 at 11:05 pm

PK AIM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161825
510(k) Type
Traditional
Applicant
GYRUS ACMI INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/26/2016
Days to Decision
87 days
Submission Type
Summary

PK AIM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161825
510(k) Type
Traditional
Applicant
GYRUS ACMI INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/26/2016
Days to Decision
87 days
Submission Type
Summary