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FDA 510(k)

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

K-Number: K213485 · 2022-05-25

ApplicantShenzhen AOJ Medical Technology Co., Ltd.
Decision Date2022-05-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E 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 2022-05-25 under 510(k) number K213485. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E?

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K213485.

When did Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E receive FDA 510(k) clearance?

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E received FDA 510(k) clearance on 2022-05-25, under 510(k) number K213485.

Who is the listed applicant for Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E?

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 Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E?

The FDA product code for Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E is FLL.

Other records listing Shenzhen AOJ Medical Technology 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.

K260276Arm Blood Pressure Monitor Models: 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 ProK250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist BlooK244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);K250116Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)

View all 17 devices →

Related Devices (Code: FLL)

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.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

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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