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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
Predetermined Change
Control Plan Authorized		 No
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