510(k) K253107

Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) by Shenzhen Dongjiang Technology Co., Ltd. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2026
Date Received
September 24, 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