CCS-200 SPIROMETER

Spirometer, Diagnostic

BENSON MEDICAL INSTRUMENTS CO.

The following data is part of a premarket notification filed by Benson Medical Instruments Co. with the FDA for Ccs-200 Spirometer.

Pre-market Notification Details

Device IDK123896
510k NumberK123896
Device Name:CCS-200 SPIROMETER
ClassificationSpirometer, Diagnostic
Applicant BENSON MEDICAL INSTRUMENTS CO. 310FOURTH AVE SOUTH SUITE 5000 Minneapolis,  MN  55415
ContactDavid Mayou
CorrespondentDavid Mayou
BENSON MEDICAL INSTRUMENTS CO. 310FOURTH AVE SOUTH SUITE 5000 Minneapolis,  MN  55415
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-18
Decision Date2013-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B207500434100 K123896 000
B2075003470 K123896 000
B207500326100 K123896 000

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