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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 K213754
Device Name SpiroHome Personal, SpiroHome Clinic
Applicant
Inofab Saglik Teknolojileri A.S
Odtu Teknokent, Silikon Blok 17/115
Cankaya, Ankara,  TR 06800
Applicant Contact Deniz Sarp
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/30/2021
Decision Date 06/12/2023
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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