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FDA 510(k)

NovaLine SP-C35 Transducer Protector (956007)

K-Number: K240164 · 2024-06-28

ApplicantBain Medical Equipment (Guangzhou) Co., Ltd.
Decision Date2024-06-28
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NovaLine SP-C35 Transducer Protector (956007) is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-28 under 510(k) 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. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K240164.

When did NovaLine SP-C35 Transducer Protector (956007) receive FDA 510(k) clearance?

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

Who is the listed applicant for NovaLine SP-C35 Transducer Protector (956007)?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Bain Medical Equipment (Guangzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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