510(k) K222394
K222394 is an FDA 510(k) premarket notification submitted by Qingdao Yasee Medical Device Co., Ltd. for the device "Electronic Sphygmomanometers". The FDA issued a decision of Substantially Equivalent on Mar 3, 2023. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Qingdao Yasee Medical Device Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 2023
- Date Received
- Aug 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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)