510(k) K201467
K201467 is an FDA 510(k) premarket notification submitted by Bioland Technology, Ltd. for the device "Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B". The FDA issued a decision of Substantially Equivalent on Sep 21, 2020. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Bioland Technology, Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2020
- Date Received
- Jun 2, 2020
- Clearance Type
- Traditional
- 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)