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FDA 510(k)

TEMPERATURE MONITOR 130/131/133

K-Number: K812037 · 1981-07-28

ApplicantMedix Medical Electronics (U.S.A.), Inc.
Decision Date1981-07-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPERATURE MONITOR 130/131/133 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812037. 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 TEMPERATURE MONITOR 130/131/133?

TEMPERATURE MONITOR 130/131/133 is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K812037.

When did TEMPERATURE MONITOR 130/131/133 receive FDA 510(k) clearance?

TEMPERATURE MONITOR 130/131/133 received FDA 510(k) clearance on 1981-07-28, under 510(k) number K812037.

Who is the listed applicant for TEMPERATURE MONITOR 130/131/133?

The FDA 510(k) record lists Medix Medical Electronics (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPERATURE MONITOR 130/131/133?

The FDA product code for TEMPERATURE MONITOR 130/131/133 is FLL.

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Other records listing Medix Medical Electronics (U.S.A.), Inc. as applicant

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K861040ENTERNAL INFUSER MULTIPUMP 203K861001PARENTERAL INFUSER MEDIPUMP 204K853393INSULIN PUMP INSUMAT 229K852433INFUSAFE 205 CATOLOG NO. 205.000K813562SYRINGE DRIVER 209K812039SPIROMETER 210/211

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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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