K260134
- 510(k) number
- K260134
- Device name
- Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- BTA — Pump, Portable, Aspiration (Manual Or Powered)
- Decision date
- 2026-05-15
- Date received
- 2026-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260134.pdf
Official FDA record: K260134
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.