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FDA 510(k)

M5T INSTANT FEVER THERMOMETER

K-Number: K012217 · 2001-08-01

ApplicantMedisim, Ltd.
Decision Date2001-08-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

M5T INSTANT FEVER THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Medisim, Ltd.. It received FDA 510(k) clearance on 2001-08-01 under 510(k) number K012217. 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 M5T INSTANT FEVER THERMOMETER?

M5T INSTANT FEVER THERMOMETER is a medical device that received FDA 510(k) clearance on 2001-08-01. The listed applicant is Medisim, Ltd.. The 510(k) number is K012217.

When did M5T INSTANT FEVER THERMOMETER receive FDA 510(k) clearance?

M5T INSTANT FEVER THERMOMETER received FDA 510(k) clearance on 2001-08-01, under 510(k) number K012217.

Who is the listed applicant for M5T INSTANT FEVER THERMOMETER?

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

What is the FDA product code for M5T INSTANT FEVER THERMOMETER?

The FDA product code for M5T INSTANT FEVER THERMOMETER is FLL.

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Other records listing Medisim, 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.

K131155UGFT3; FHT7K090386NON-INVASIVE INFRARED (NIR)K051422DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICEK032362UP-GRADE FOREHEAD THERMOMETERK983887UP-GRADE AND UP-GRADE PRO

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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