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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K142303
Device Name NeumoFilt Ergo/Neumo Filt BiteOn
Applicant
Medical Respiratory Devices S.L.
Avda. De Las Americas 4, Nave A7
Coslada(Madrid),  ES 28823
Applicant Contact Jose Alberto Hernandez
Correspondent
Medical Respiratory Devices S.L.
Avda. De Las Americas 4, Nave A7
Coslada(Madrid),  ES 28823
Correspondent Contact Paul Dryden
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/18/2014
Decision Date 11/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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