FDA 510(k) Application Details - K172862

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K172862
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Andon Health Co., Ltd. No. 3 Jin Ping Street Ya An Road, Nankai District Tianjin 300190 CN Other 510(k) Applications for this Company
Contact	Liu Yi 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	09/20/2017
Decision Date	07/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review