510(k) K211127
K211127 is an FDA 510(k) premarket notification submitted by Health & Life Co., Ltd. for the device "Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM". The FDA issued a decision of Substantially Equivalent on Sep 8, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Health & Life Co., Ltd. has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 2021
- Date Received
- Apr 16, 2021
- 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)