FDA 510(k) Application Details - K200832

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K200832
Device Name	Meter, Peak Flow, Spirometry
Applicant	Safey Medical Devices Pvt Ltd 3rd Floor, Office 303, Nyati Emporius, S no 105 H no 4A, Baner Pune 411045 IN Other 510(k) Applications for this Company
Contact	Taher Ali Moiyed 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	03/30/2020
Decision Date	07/30/2020
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