FDA 510(k) Application Details - K231416

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K231416
Device Name	Spirometer, Diagnostic
Applicant	NuvoAir AB 17D Riddargatan Stockholm, SE 11457 Stockholm SE Other 510(k) Applications for this Company
Contact	Furat Shawki 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	05/16/2023
Decision Date	01/18/2024
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