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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K852439
Device Name FETA SCAN 1000 OBSTETRICAL IMAGER
Applicant
International Biomedics, Inc.
P.O. Box 971
Mercer Island,  WA  98040
Applicant Contact HOWARD M HOCHBERG
Correspondent
International Biomedics, Inc.
P.O. Box 971
Mercer Island,  WA  98040
Correspondent Contact HOWARD M HOCHBERG
Regulation Number884.2225
Classification Product Code
HEM  
Date Received06/10/1985
Decision Date 08/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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