510(k) K182220

Curbell branded Patient Monitoring Cables by Curbell Medical Products, Inc. — Product Code DSA

K182220 is an FDA 510(k) premarket notification submitted by Curbell Medical Products, Inc. for the device "Curbell branded Patient Monitoring Cables". The FDA issued a decision of Substantially Equivalent on Nov 7, 2018. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 7, 2018
Date Received
Aug 15, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type
510(k)