510(k) K163607
K163607 is an FDA 510(k) premarket notification submitted by Vales & Hills Biomedical Tech. , Ltd. for the device "ECG Acquisition Systems". The FDA issued a decision of Substantially Equivalent on December 15, 2017. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Vales & Hills Biomedical Tech. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2017
- Date Received
- December 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type