FDA 510(k) Application Details - K201644

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K201644
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Qardio Inc. 345 California Street, Suite 600 & 700 San Francisco, CA 94104 US Other 510(k) Applications for this Company
Contact	Rosario Iannella Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2020
Decision Date	02/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review