510(k) K172797
K172797 is an FDA 510(k) premarket notification submitted by Shenzhen Coreray Technology, Ltd. for the device "ECG Cable/Leadwires". The FDA issued a decision of Substantially Equivalent on Feb 28, 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. Shenzhen Coreray Technology, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2018
- Date Received
- Sep 15, 2017
- 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)