510(k) K153188
K153188 is an FDA 510(k) premarket notification submitted by Shenzhen Caremed Medical Technology Co., Ltd. for the device "Caremed patient cable and leadwires". The FDA issued a decision of Substantially Equivalent on Oct 24, 2016. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Shenzhen Caremed Medical Technology Co., Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 2016
- Date Received
- Nov 3, 2015
- Clearance Type
- Traditional
- 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)