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FDA 510(k)

MODEL TM101 TEMPERATURE MONITOR

K-Number: K902386 · 1992-01-28

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1992-01-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL TM101 TEMPERATURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Electronics , Ltd.. It received FDA 510(k) clearance on 1992-01-28 under 510(k) number K902386. 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 MODEL TM101 TEMPERATURE MONITOR?

MODEL TM101 TEMPERATURE MONITOR is a medical device that received FDA 510(k) clearance on 1992-01-28. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K902386.

When did MODEL TM101 TEMPERATURE MONITOR receive FDA 510(k) clearance?

MODEL TM101 TEMPERATURE MONITOR received FDA 510(k) clearance on 1992-01-28, under 510(k) number K902386.

Who is the listed applicant for MODEL TM101 TEMPERATURE MONITOR?

The FDA 510(k) record lists Fisher & Paykel Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL TM101 TEMPERATURE MONITOR?

The FDA product code for MODEL TM101 TEMPERATURE MONITOR is FLL.

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Other records listing Fisher & Paykel Electronics , Ltd. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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