FDA 510(k) Application Details - K203638

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K203638
Device Name	Recorder, Magnetic Tape, Medical
Applicant	ATsens Co., Ltd Point Town 806, 11, Gumi-ro, Bundang-gu Seongnam-si 13637 KR Other 510(k) Applications for this Company
Contact	KeonHoon Lee 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	12/14/2020
Decision Date	10/12/2022
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