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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 K201002
Device Name Safey Pocket Spirometer
Applicant
Safey Medical Devices Pvt Ltd
3rd Floor, Office 303, Nyati Emporius, S no 105 H no 4A,
Baner
Pune,  IN 411045
Applicant Contact Taher Ali Moiyed
Correspondent
Safey Medical Devices Pvt Ltd
3rd Floor, Office 303, Nyati Emporius, S no 105 H no 4A,
Baner
Pune,  IN 411045
Correspondent Contact Taher Ali Moiyed
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/16/2020
Decision Date 07/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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