EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

Calculator, Predicted Values, Pulmonary Function

NDD MEDIZITECHNIK AG

The following data is part of a premarket notification filed by Ndd Medizitechnik Ag with the FDA for Easyone Pro Respiratory Analysis System.

Pre-market Notification Details

Device IDK091428
510k NumberK091428
Device Name:EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant NDD MEDIZITECHNIK AG TWO DUNDEE PARK Andover,  MA  01810
ContactGerard Masiello
CorrespondentGerard Masiello
NDD MEDIZITECHNIK AG TWO DUNDEE PARK Andover,  MA  01810
Product CodeBTY  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-14
Decision Date2010-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640142190349 K091428 000

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