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FDA 510(k)

THERMOMETER MODELS ST8631

K-Number: K021048 · 2002-04-22

ApplicantZ7 International
Decision Date2002-04-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOMETER MODELS ST8631 is the device name listed in this FDA 510(k) record. The listed applicant is Z7 International. It received FDA 510(k) clearance on 2002-04-22 under 510(k) number K021048. 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 THERMOMETER MODELS ST8631?

THERMOMETER MODELS ST8631 is a medical device that received FDA 510(k) clearance on 2002-04-22. The listed applicant is Z7 International. The 510(k) number is K021048.

When did THERMOMETER MODELS ST8631 receive FDA 510(k) clearance?

THERMOMETER MODELS ST8631 received FDA 510(k) clearance on 2002-04-22, under 510(k) number K021048.

Who is the listed applicant for THERMOMETER MODELS ST8631?

The FDA 510(k) record lists Z7 International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOMETER MODELS ST8631?

The FDA product code for THERMOMETER MODELS ST8631 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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