电动吸奶器（型号7V和7X）
K号: K211016 · 2022-06-29
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决定日期2022-06-29
产品代码HGX
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Powered Breast Pump (Models 7V and 7X) is the device name listed in this FDA 510(k) record. The listed applicant is Haenim Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K211016. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Powered Breast Pump (Models 7V and 7X)?
Powered Breast Pump (Models 7V and 7X) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Haenim Co., Ltd.. The 510(k) number is K211016.
When did Powered Breast Pump (Models 7V and 7X) receive FDA 510(k) clearance?
Powered Breast Pump (Models 7V and 7X) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K211016.
Who is the listed applicant for Powered Breast Pump (Models 7V and 7X)?
The FDA 510(k) record lists Haenim Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Powered Breast Pump (Models 7V and 7X)?
The FDA product code for Powered Breast Pump (Models 7V and 7X) is HGX.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：HGX）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254203可穿戴式乳腺泵（型号S36）Shenzhen TPH Technology Co., Ltd.K261622飞利浦新安怡自然护理免手提电动吸奶器（型号：SCF593/52，SCF593/62）；飞利浦新安怡自然护理加热免手提电动吸奶器（型号：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774可穿戴式乳腺泵（型号：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre 双重最大Cimilre Co., Ltd.K261298可穿戴电动吸奶器（YM-8837，YM-8838，YM-8856(H03)，YM-8809(S42)）Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流动式穿戴型乳房吸奶器（型号 S3）Shenzhen TPH Technology Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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