510(k) K172739
K172739 is an FDA 510(k) premarket notification submitted by Higi Sh, LLC for the device "higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)". The FDA issued a decision of Substantially Equivalent on Oct 10, 2017. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Higi Sh, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 10, 2017
- Date Received
- Sep 12, 2017
- 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)