FETA SCAN 1000 OBSTETRICAL IMAGER

Imager, Ultrasonic Obstetric-gynecologic

INTERNATIONAL BIOMEDICS, INC.

The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Feta Scan 1000 Obstetrical Imager.

Pre-market Notification Details

Device IDK852439
510k NumberK852439
Device Name:FETA SCAN 1000 OBSTETRICAL IMAGER
ClassificationImager, Ultrasonic Obstetric-gynecologic
Applicant INTERNATIONAL BIOMEDICS, INC. P.O. BOX 971 Mercer Island,  WA  98040
ContactHoward M Hochberg
CorrespondentHoward M Hochberg
INTERNATIONAL BIOMEDICS, INC. P.O. BOX 971 Mercer Island,  WA  98040
Product CodeHEM  
CFR Regulation Number884.2225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-10
Decision Date1985-08-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.