510(k) K222547
K222547 is an FDA 510(k) premarket notification submitted by Shenzhen Xinlianfeng Technology Co.,Ltd for the device "Electric nasal aspirator". The FDA issued a decision of Substantially Equivalent on Oct 20, 2022. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 2022
- Date Received
- Aug 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
- 510(k)