K240164
- 510(k) number
- K240164
- Device name
- NovaLine SP-C35 Transducer Protector (956007)
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd. CN
- Product code
- FIB — Protector, Transducer, Dialysis
- Decision date
- 2024-06-28
- Date received
- 2024-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240164.pdf
Official FDA record: K240164
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.