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FDA 510(k)

RTM SYSTEM (REMOTE TEMPERATURE MONITOR)

K-Number: K801423 · 1980-08-27

ApplicantRemote Technologies, Inc.
Decision Date1980-08-27
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RTM SYSTEM (REMOTE TEMPERATURE MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Remote Technologies, Inc.. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801423. 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 RTM SYSTEM (REMOTE TEMPERATURE MONITOR)?

RTM SYSTEM (REMOTE TEMPERATURE MONITOR) is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Remote Technologies, Inc.. The 510(k) number is K801423.

When did RTM SYSTEM (REMOTE TEMPERATURE MONITOR) receive FDA 510(k) clearance?

RTM SYSTEM (REMOTE TEMPERATURE MONITOR) received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801423.

Who is the listed applicant for RTM SYSTEM (REMOTE TEMPERATURE MONITOR)?

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

What is the FDA product code for RTM SYSTEM (REMOTE TEMPERATURE MONITOR)?

The FDA product code for RTM SYSTEM (REMOTE TEMPERATURE MONITOR) is FLL.

Related Clinical Trials

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.

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Other records listing Remote Technologies, 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.

K912323THE REMOTE

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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