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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K203378
Device Name Pulsehaler
Applicant
Respinova, Ltd.
Hachoshlim 8
Herzliya,  IL 4672408
Applicant Contact Cliff Ansel
Correspondent
Ironstone Product Development, Inc.
250 Carlaw Ave., Suite 108
Toronto,  CA M4M 3L1
Correspondent Contact Joel Ironstone
Regulation Number868.5690
Classification Product Code
BWF  
Date Received11/17/2020
Decision Date 03/31/2021
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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