FDA 510(k) Application Details - K230184

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K230184
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Lavender Wang 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	01/23/2023
Decision Date	09/25/2023
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