FDA 510(k) Application Details - K210179

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K210179
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Quanta Computer Inc. No. 188, Wenhua 2nd Road, Guishan District Taoyuan City 33377 TW Other 510(k) Applications for this Company
Contact	Vivian Yang 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	01/22/2021
Decision Date	08/02/2022
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