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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K860295
Device Name FETASCAN 1500
Applicant
INTERNATIONAL BIOMEDICS, INC.
1631 220TH AVE. S.E.
(PER DO, FIRM OOB)
BOTHELL,  WA  98021
Applicant Contact HOWARD M HOCHBERG
Correspondent
INTERNATIONAL BIOMEDICS, INC.
1631 220TH AVE. S.E.
(PER DO, FIRM OOB)
BOTHELL,  WA  98021
Correspondent Contact HOWARD M HOCHBERG
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/28/1986
Decision Date 05/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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