510(k) K113083
K113083 is an FDA 510(k) premarket notification submitted by Truly Instrument Co., Ltd. for the device "TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on Jan 19, 2012. 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 Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 2012
- Date Received
- Oct 18, 2011
- 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)