510(k) K262822
K262822 is an FDA 510(k) premarket notification submitted by Zhongshan GL Electronics Co. , Ltd. for the device "Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)". The FDA issued a decision of Substantially Equivalent on Oct 7, 2026. 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 7, 2026
- Date Received
- Aug 10, 2026
- 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)