FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

Transducer, Ultrasonic, Obstetric

INTERNATIONAL BIOMEDICS, INC.

The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Fetascan Ultrasound Transducer Ibi# 101b00054-01.

Pre-market Notification Details

Device IDK862072
510k NumberK862072
Device Name:FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
ClassificationTransducer, Ultrasonic, Obstetric
Applicant INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell,  WA  98021
ContactHochberg, Md
CorrespondentHochberg, Md
INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell,  WA  98021
Product CodeHGL  
CFR Regulation Number884.2960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-30
Decision Date1986-07-09

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