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FDA 510(k)

DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300

K-Number: K070878 · 2007-06-05

ApplicantRg Medical Diagnostics
Decision Date2007-06-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 is the device name listed in this FDA 510(k) record. The listed applicant is Rg Medical Diagnostics. It received FDA 510(k) clearance on 2007-06-05 under 510(k) number K070878. 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 DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300?

DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 is a medical device that received FDA 510(k) clearance on 2007-06-05. The listed applicant is Rg Medical Diagnostics. The 510(k) number is K070878.

When did DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 receive FDA 510(k) clearance?

DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 received FDA 510(k) clearance on 2007-06-05, under 510(k) number K070878.

Who is the listed applicant for DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300?

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

What is the FDA product code for DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300?

The FDA product code for DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 is FLL.

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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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