510(k) K240164
K240164 is an FDA 510(k) premarket notification submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. for the device "NovaLine SP-C35 Transducer Protector (956007)". The FDA issued a decision of Substantially Equivalent on June 28, 2024. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Bain Medical Equipment (Guangzhou) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2024
- Date Received
- January 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Transducer, Dialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type