AIR-CUSHION TOCOTONOMETER

Monitor, Uterine Contraction, External (for Use In Clinic)

INTERNATIONAL BIOMEDICS, INC.

The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Air-cushion Tocotonometer.

Pre-market Notification Details

Device IDK860933
510k NumberK860933
Device Name:AIR-CUSHION TOCOTONOMETER
ClassificationMonitor, Uterine Contraction, External (for Use In Clinic)
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 CodeHFM  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-12
Decision Date1986-07-09

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