FDA 510(k)

电动吸奶器 (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

K号: K241322 · 2024-12-19

决定日期2024-12-19

产品代码HGX

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决定实质等同

器械摘要

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K241322. 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 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K241322.

When did Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) receive FDA 510(k) clearance?

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K241322.

Who is the listed applicant for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?

FDA 510(k)记录将Joytech Healthcare Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?

The FDA product code for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is HGX.

列明Joytech Healthcare Co. , Ltd.为申报人的其他记录

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。

K261394臂式全自动数字血压计（DBP-6186 Plus，DBP-6286B Plus，DBP-61E3 Plus，DBP-61E2 Plus，DBP-62E3B Plus，DBP-62E2B Plus）K253425臂式全自动数字血压计（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）K252501手臂式全自动数字血压计（DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L）K252685手臂式全自动数字血压计（DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P）K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）K250548手臂式全自动数字血压计（DBP-6286B, DBP-6186）

查看所有 24 个设备 →

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

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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。