FDA 510(k) Application Details - K193311

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K193311
Device Name	Meter, Peak Flow, Spirometry
Applicant	Knox Medical Diagnostics, Inc. 345 California Street, Suite 600 San Francisco, CA 94104 US Other 510(k) Applications for this Company
Contact	Charvi Shetty 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	11/29/2019
Decision Date	03/25/2020
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