Last synced on 25 January 2026 at 3:41 am

PKS OMNI INSTRUMENT

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081766
510(k) Type
Traditional
Applicant
Gyrus-Acmi L.P.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2008
Days to Decision
49 days
Submission Type
Summary

PKS OMNI INSTRUMENT

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081766
510(k) Type
Traditional
Applicant
Gyrus-Acmi L.P.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2008
Days to Decision
49 days
Submission Type
Summary