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510(k) Data Aggregation
K Number
K993921Device Name
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
Manufacturer
NDD MEDICAL TECHNOLOGIES
Date Cleared
2000-05-23
(187 days)
Product Code
BZG, DAT
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
NDD MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
Device Description
The ndd EasyOne™ Spirometer system consists of the following: EasyOne™ Spirometer (either the Frontline Model 2000 or the Diagnostic Model 2001) Disposable Spirette Cal coupler (used to connect the spirometer to the calibration syringe) EasyStart User Instructions EasyGuide Technical Information EasyOne™ Cradle (optional) Printer cable (optional) Two AA alkaline batteries
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