FDA 510(k) Application Details - K160837

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K160837
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	MEDINET SRL VIA LONDONIO, 12 MILANO 20154 IT Other 510(k) Applications for this Company
Contact	STEFANO BERNUCCI Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2016
Decision Date	02/23/2017
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