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FDA 510(k)

DIGITAL CLINICAL THERMOMETER MODEL V9XX

K-Number: K082266 · 2008-11-07

ApplicantAmperor-Electronic(Sz) Co., Ltd.
Decision Date2008-11-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGITAL CLINICAL THERMOMETER MODEL V9XX is the device name listed in this FDA 510(k) record. The listed applicant is Amperor-Electronic(Sz) Co., Ltd.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082266. 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 CLINICAL THERMOMETER MODEL V9XX?

DIGITAL CLINICAL THERMOMETER MODEL V9XX is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Amperor-Electronic(Sz) Co., Ltd.. The 510(k) number is K082266.

When did DIGITAL CLINICAL THERMOMETER MODEL V9XX receive FDA 510(k) clearance?

DIGITAL CLINICAL THERMOMETER MODEL V9XX received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082266.

Who is the listed applicant for DIGITAL CLINICAL THERMOMETER MODEL V9XX?

The FDA 510(k) record lists Amperor-Electronic(Sz) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL CLINICAL THERMOMETER MODEL V9XX?

The FDA product code for DIGITAL CLINICAL THERMOMETER MODEL V9XX is FLL.

Related Clinical Trials

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.

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Other records listing Amperor-Electronic(Sz) 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.

K112116DIGITAL CLINICAL THERMOMETER MODEL V901US

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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