510(k) K250697
K250697 is an FDA 510(k) premarket notification submitted by Shenzhen Kingboom Technology Co., Ltd. for the device "Electric Nasal Aspirator (BC026, BC025, BC023)". The FDA issued a decision of Substantially Equivalent on April 23, 2025. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Shenzhen Kingboom Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2025
- Date Received
- March 7, 2025
- 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