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FDA 510(k)

TEMPROBE MONITOR

K-Number: K840648 · 1984-06-05

ApplicantVital Signs, Inc.
Decision Date1984-06-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPROBE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1984-06-05 under 510(k) number K840648. 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 TEMPROBE MONITOR?

TEMPROBE MONITOR is a medical device that received FDA 510(k) clearance on 1984-06-05. The listed applicant is Vital Signs, Inc.. The 510(k) number is K840648.

When did TEMPROBE MONITOR receive FDA 510(k) clearance?

TEMPROBE MONITOR received FDA 510(k) clearance on 1984-06-05, under 510(k) number K840648.

Who is the listed applicant for TEMPROBE MONITOR?

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

What is the FDA product code for TEMPROBE MONITOR?

The FDA product code for TEMPROBE MONITOR 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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