FDA 510(k) Application Details - K163249

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K163249
Device Name	Spirometer, Diagnostic
Applicant	MONITORED THERAPEUTICS, INC. 5940 VENTURE DR., SUITE C DUBLIN, OH 43017 US Other 510(k) Applications for this Company
Contact	William Zimlich 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	11/18/2016
Decision Date	03/24/2017
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