510(k) K091897
K091897 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019". The FDA issued a decision of Substantially Equivalent on Aug 25, 2009. 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
- Aug 25, 2009
- Date Received
- Jun 24, 2009
- 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)