510(k) K112216
K112216 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 22, 2011. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Taidoc Technology Corporation has 122 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2011
- Date Received
- Aug 2, 2011
- 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)