FDA 510(k) Application Details - K182220

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K182220
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Curbell Medical Products, Inc. 20 Centre Drive Orchard Park, NY 14127 US Other 510(k) Applications for this Company
Contact	Michael Winter 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	08/15/2018
Decision Date	11/07/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review