FDA 510(k) Application Details - K220447

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K220447
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Shenzhen Med-link Electronics Tech Co., Ltd. 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Yi Liu Other 510(k) Applications for this Contact
Regulation Number	870.2900   More FDA Info for this Regulation Number
Classification Product Code	DSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2022
Decision Date	06/28/2022
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