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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
Respinova Ltd.
Hachoshlim 8
Herzliya,  IL 4672408
Applicant Contact Cliff Ansel
Ironstone Product Development Inc.
250 Carlaw Avenue
Suite 108
Toronto,  CA M4M 3L1
Correspondent Contact Joel Ironstone
Regulation Number868.5690
Classification Product Code
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