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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K061153
Device Name GYNESONICS EC6 TRANSDUCER
Applicant
Gynesonics, Inc.
604 Fifth Ave.
Suite D
Redwood City,  CA  94063
Applicant Contact JESSICA GROSSMAN, MD
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/26/2006
Decision Date 10/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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