INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING

Meter, Airway Pressure (inspiratory Force)

DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.

The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Inspiratory Force Mont Kit/manifold/meter/tubing.

Pre-market Notification Details

Device IDK873498
510k NumberK873498
Device Name:INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
ClassificationMeter, Airway Pressure (inspiratory Force)
Applicant DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota,  NY  13032
ContactJean Wallace
CorrespondentJean Wallace
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota,  NY  13032
Product CodeBXR  
CFR Regulation Number868.1780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-31
Decision Date1988-03-09

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