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FDA 510(k)

EASYTEM EAR THERMOMETER, MODEL BT-020

K-Number: K020520 · 2002-08-06

ApplicantMetatech Co., Ltd.
Decision Date2002-08-06
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EASYTEM EAR THERMOMETER, MODEL BT-020 is the device name listed in this FDA 510(k) record. The listed applicant is Metatech Co., Ltd.. It received FDA 510(k) clearance on 2002-08-06 under 510(k) number K020520. 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 EASYTEM EAR THERMOMETER, MODEL BT-020?

EASYTEM EAR THERMOMETER, MODEL BT-020 is a medical device that received FDA 510(k) clearance on 2002-08-06. The listed applicant is Metatech Co., Ltd.. The 510(k) number is K020520.

When did EASYTEM EAR THERMOMETER, MODEL BT-020 receive FDA 510(k) clearance?

EASYTEM EAR THERMOMETER, MODEL BT-020 received FDA 510(k) clearance on 2002-08-06, under 510(k) number K020520.

Who is the listed applicant for EASYTEM EAR THERMOMETER, MODEL BT-020?

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

What is the FDA product code for EASYTEM EAR THERMOMETER, MODEL BT-020?

The FDA product code for EASYTEM EAR THERMOMETER, MODEL BT-020 is FLL.

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Other records listing Metatech 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.

K033077EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021K0330829 SECOND DIGITAL THERMOMETER, MODEL BT-S09

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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