K240164 is an FDA 510(k) clearance for the NovaLine SP-C35 Transducer Protector (956007). This device is classified as a Protector, Transducer, Dialysis (Class II - Special Controls, product code FIB).
Submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 28, 2024, 158 days after receiving the submission on January 22, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K240164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2024 |
| Decision Date | June 28, 2024 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIB - Protector, Transducer, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |