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FDA 510(k)

BEHIND EAR GENTLE TOUCH THERMOMETER

K-Number: K103839 · 2011-06-06

ApplicantKaz, Inc.
Decision Date2011-06-06
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BEHIND EAR GENTLE TOUCH THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Kaz, Inc.. It received FDA 510(k) clearance on 2011-06-06 under 510(k) number K103839. 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 BEHIND EAR GENTLE TOUCH THERMOMETER?

BEHIND EAR GENTLE TOUCH THERMOMETER is a medical device that received FDA 510(k) clearance on 2011-06-06. The listed applicant is Kaz, Inc.. The 510(k) number is K103839.

When did BEHIND EAR GENTLE TOUCH THERMOMETER receive FDA 510(k) clearance?

BEHIND EAR GENTLE TOUCH THERMOMETER received FDA 510(k) clearance on 2011-06-06, under 510(k) number K103839.

Who is the listed applicant for BEHIND EAR GENTLE TOUCH THERMOMETER?

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

What is the FDA product code for BEHIND EAR GENTLE TOUCH THERMOMETER?

The FDA product code for BEHIND EAR GENTLE TOUCH THERMOMETER is FLL.

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Other records listing Kaz, Inc. 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.

K950116THERASTEAM PERSONAL STEAM INHALER

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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