NovaLine SP-C35 Transducer Protector (956007)— 510(k) K240164

Substantially Equivalent

Bain Medical Equipment (Guangzhou) Co., Ltd.

FDA 510(k) clearance K240164 for NovaLine SP-C35 Transducer Protector (956007), Substantially Equivalent on 2024-06-28. Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code
Code FIB
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guangzhou, CN
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