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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name meter, peak flow, spirometry
510(k) Number K180487
Device Name Peak.me
Breathe me LTD
13 Zarchin street
Ra'anana,  IL 4366241
Applicant Contact Yoram Levy
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number868.1860
Classification Product Code
Date Received02/23/2018
Decision Date 10/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No