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FDA 510(k)

Swaive Thermometer SWT1A

K-Number: K170723 · 2018-10-25

ApplicantE-Care Technology Co., Ltd.
Decision Date2018-10-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Swaive Thermometer SWT1A is the device name listed in this FDA 510(k) record. The listed applicant is E-Care Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K170723. 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 Swaive Thermometer SWT1A?

Swaive Thermometer SWT1A is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is E-Care Technology Co., Ltd.. The 510(k) number is K170723.

When did Swaive Thermometer SWT1A receive FDA 510(k) clearance?

Swaive Thermometer SWT1A received FDA 510(k) clearance on 2018-10-25, under 510(k) number K170723.

Who is the listed applicant for Swaive Thermometer SWT1A?

The FDA 510(k) record lists E-Care Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Swaive Thermometer SWT1A?

The FDA product code for Swaive Thermometer SWT1A is FLL.

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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