510(k) K170545
K170545 is an FDA 510(k) premarket notification submitted by Truly Instrument , Ltd. for the device "Automatic Wrist Bluetooth Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on Nov 21, 2017. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 21, 2017
- Date Received
- Feb 24, 2017
- Clearance Type
- Abbreviated
- 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)