510(k) K161846
K161846 is an FDA 510(k) premarket notification submitted by Truly Instrument Limited for the device "Automatic Arm Bluetooth Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on Oct 24, 2016. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Truly Instrument Limited has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 2016
- Date Received
- Jul 5, 2016
- 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)