510(k) K163113
K163113 is an FDA 510(k) premarket notification submitted by Grandway Technology (Shenzhen) Limited for the device "Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series". The FDA issued a decision of Substantially Equivalent on Jan 19, 2017. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Grandway Technology (Shenzhen) Limited has 20 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 2017
- Date Received
- Nov 7, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)