FDA 510(k)

脉搏血氧仪（AOJ-70A）；脉搏血氧仪（AOJ-70B）；脉搏血氧仪（AOJ-70C）；脉搏血氧仪（AOJ-70D）；脉搏血氧仪（AOJ-70E）

K号: K232989 · 2024-07-01

申请人Shenzhen AOJ Medical Technology Co., Ltd.

决定日期2024-07-01

产品代码DQA

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K232989. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)?

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K232989.

When did Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) receive FDA 510(k) clearance?

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) received FDA 510(k) clearance on 2024-07-01, under 510(k) number K232989.

Who is the listed applicant for Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)?

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

What is the FDA product code for Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)?

The FDA product code for Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) is DQA.

列明Shenzhen AOJ Medical Technology 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。

K260276上臂血压计型号：ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro K250470耳温计（EAR-E101）；耳温计（EAR-E102）；耳温计（EAR-E103）K250161腕式血压计（AOJ-35A）；腕式血压计（AOJ-35B）；腕式血压计（WRS-35B）；腕式血压计（AOJ-35D）；腕式血压计（AOJ-35E）；腕式血压计（AOJ-35F）；腕式血压计（AOJ-35G）；腕式血压计（WRS-35G）；腕式血压计（WRS-35H）；腕式血压计（WRS-35K）；腕式血压计（WRS-35N）；腕式血压计（WRS-35P）；腕式血压计（WRS-35P）K244000上臂血压计 (ARM-30A+);上臂血压计 (ARM-30G2);上臂血压计 (ARM-30Q);上臂血压计 (ARM-30E+);K250116上臂血压计 (ARM-30H); 上臂血压计 (ARM-30J); 上臂血压计 (ARM-30K); 上臂血压计 (ARM-90B)K232128红外体温计（AOJ-20A）；红外体温计（AOJ-20Y）

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