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FDA 510(k)

FORA COMFORTSCAN EAR THERMOMETER

K-Number: K121118 · 2012-06-15

ApplicantForacare, Inc.
Decision Date2012-06-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FORA COMFORTSCAN EAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Foracare, Inc.. It received FDA 510(k) clearance on 2012-06-15 under 510(k) number K121118. 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 FORA COMFORTSCAN EAR THERMOMETER?

FORA COMFORTSCAN EAR THERMOMETER is a medical device that received FDA 510(k) clearance on 2012-06-15. The listed applicant is Foracare, Inc.. The 510(k) number is K121118.

When did FORA COMFORTSCAN EAR THERMOMETER receive FDA 510(k) clearance?

FORA COMFORTSCAN EAR THERMOMETER received FDA 510(k) clearance on 2012-06-15, under 510(k) number K121118.

Who is the listed applicant for FORA COMFORTSCAN EAR THERMOMETER?

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

What is the FDA product code for FORA COMFORTSCAN EAR THERMOMETER?

The FDA product code for FORA COMFORTSCAN EAR THERMOMETER is FLL.

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Other records listing Foracare, 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.

K173505FORA GTel Blood Glucose Monitoring SystemK121706FORA V10 BLOOD GLUCOSE MONITORING SYSTEMK110044FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM

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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