Last synced on 14 November 2025 at 11:06 pm

PKS OMNI INSTRUMENT

Page Type
Cleared 510(K)
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)
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