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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K161295
Device Name MiniBox +
Applicant
Pulmone Advanced Medical Devices, Ltd.
14 Hacharoshet St.
Ra’Ananna,  IL 4365707
Applicant Contact Avi Lazar
Correspondent
Sfa Consulting, LLC
200 Park Ave., Unit 111
Minneapolis,  MN  55415
Correspondent Contact Susan Alpert
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Code
BZG  
Date Received05/09/2016
Decision Date 10/21/2016
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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