FETASCAN 1500

System, Monitoring, Perinatal

INTERNATIONAL BIOMEDICS, INC.

The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Fetascan 1500.

Pre-market Notification Details

Device IDK860295
510k NumberK860295
Device Name:FETASCAN 1500
ClassificationSystem, Monitoring, Perinatal
Applicant INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell,  WA  98021
ContactHoward M Hochberg
CorrespondentHoward M Hochberg
INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell,  WA  98021
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-28
Decision Date1986-05-19

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