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FDA 510(k)

3M SPOTON TEMPERATURE MONITORING SYSTEM

K-Number: K120412 · 2012-05-30

ApplicantArizant Healthcare, Inc.
Decision Date2012-05-30
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M SPOTON TEMPERATURE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arizant Healthcare, Inc.. It received FDA 510(k) clearance on 2012-05-30 under 510(k) number K120412. 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 3M SPOTON TEMPERATURE MONITORING SYSTEM?

3M SPOTON TEMPERATURE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Arizant Healthcare, Inc.. The 510(k) number is K120412.

When did 3M SPOTON TEMPERATURE MONITORING SYSTEM receive FDA 510(k) clearance?

3M SPOTON TEMPERATURE MONITORING SYSTEM received FDA 510(k) clearance on 2012-05-30, under 510(k) number K120412.

Who is the listed applicant for 3M SPOTON TEMPERATURE MONITORING SYSTEM?

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

What is the FDA product code for 3M SPOTON TEMPERATURE MONITORING SYSTEM?

The FDA product code for 3M SPOTON TEMPERATURE MONITORING SYSTEM is FLL.

Related Clinical Trials

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Other records listing Arizant Healthcare, 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.

K082217RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEMK060939RANGER IRRIGATION FLUID WARMING SYSTEMK060865BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850K053645MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMSK041686BAIR HUGGER TEMPERATURE MANAGEMENT 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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