FDA 510(k) Application Details - K242583

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K242583
Device Name	Recorder, Magnetic Tape, Medical
Applicant	ATsens Co.,Ltd. Point Town 803, 11, Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 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	08/30/2024
Decision Date	05/02/2025
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