Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NovaLine SP-C35 Transducer Protector (956007)

K-Number: K240164 · 2024-06-28

Decision Date2024-06-28
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NovaLine SP-C35 Transducer Protector (956007) is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-28 under approval number K240164. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovaLine SP-C35 Transducer Protector (956007)?

NovaLine SP-C35 Transducer Protector (956007) is a medical device that received FDA 510(k) clearance on 2024-06-28. It is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K240164.

When was NovaLine SP-C35 Transducer Protector (956007) approved by the FDA?

NovaLine SP-C35 Transducer Protector (956007) received FDA 510(k) clearance on 2024-06-28, under approval number K240164.

What company makes NovaLine SP-C35 Transducer Protector (956007)?

NovaLine SP-C35 Transducer Protector (956007) is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd..

What is the FDA product code for NovaLine SP-C35 Transducer Protector (956007)?

The FDA product code for NovaLine SP-C35 Transducer Protector (956007) is FIB.

Other Devices by Bain Medical Equipment (Guangzhou) Co., Ltd.

View all 7 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.