FDA 510(k) Application Details - K180487

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K180487
Device Name	Meter, Peak Flow, Spirometry
Applicant	Breathe me LTD 13 Zarchin street Ra'anana 4366241 IL Other 510(k) Applications for this Company
Contact	Yoram Levy Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2018
Decision Date	10/26/2018
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