FDA 510(k) Application Details - K150515

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K150515
Device Name	Spirometer, Diagnostic
Applicant	SDI DIAGNOSTICS, INC. 10 HAMPDEN DRIVE EASTON, MA 02375 US Other 510(k) Applications for this Company
Contact	COSIMO CARIOLO 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	03/02/2015
Decision Date	01/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review