510(k) K910212

COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST by Acoustic Imaging Technologies Corp. — Product Code JYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1991
Date Received
January 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ear
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type