FDA 510(k) Application Details - K231289

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K231289
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Wellysis Corp. 8F, 425 Teheran-ro, Gangnam-gu Seoul 06159 KR Other 510(k) Applications for this Company
Contact	DoGyun Im 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	05/04/2023
Decision Date	08/30/2023
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