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FDA 510(k)

AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101

K-Number: K042906 · 2004-11-19

ApplicantAmplife Corporation
Decision Date2004-11-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 is the device name listed in this FDA 510(k) record. The listed applicant is Amplife Corporation. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042906. 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 AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101?

AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Amplife Corporation. The 510(k) number is K042906.

When did AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 receive FDA 510(k) clearance?

AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042906.

Who is the listed applicant for AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101?

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

What is the FDA product code for AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101?

The FDA product code for AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 is FLL.

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Other records listing Amplife Corporation 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.

K050413AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600K043550AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100K042575AMPLIFE DIGITAL CLINICAL THERMOMETER

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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