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FDA 510(k)

TEMP SCAN

K-Number: K010383 · 2001-04-18

ApplicantTenghi Co., Ltd.
Decision Date2001-04-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMP SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Tenghi Co., Ltd.. It received FDA 510(k) clearance on 2001-04-18 under 510(k) number K010383. 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 TEMP SCAN?

TEMP SCAN is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Tenghi Co., Ltd.. The 510(k) number is K010383.

When did TEMP SCAN receive FDA 510(k) clearance?

TEMP SCAN received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010383.

Who is the listed applicant for TEMP SCAN?

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

What is the FDA product code for TEMP SCAN?

The FDA product code for TEMP SCAN is FLL.

Other records listing Tenghi 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.

K033069DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205

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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