FDA 510(k) Application Details - K213754

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K213754
Device Name	Spirometer, Diagnostic
Applicant	Inofab Saglik Teknolojileri A.S ODTU Teknokent, Silikon Blok 17/115 Cankaya, Ankara 06800 TR Other 510(k) Applications for this Company
Contact	Deniz Sarp Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2021
Decision Date	06/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review