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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
510(k) Number K023227
Device Name USG 2000SA
Applicant
ULTRAGUIDE LTD.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07601
Applicant Contact GEORGE MYERS
Correspondent
ULTRAGUIDE LTD.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07601
Correspondent Contact GEORGE MYERS
Regulation Number884.2225
Classification Product Code
HHJ  
Date Received09/27/2002
Decision Date 10/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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