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FDA 510(k)

DISPOSABLE THERMOMETER COVERS AND SHEATHS

K-Number: K112289 · 2011-12-16

ApplicantKang ZE Industrial Co. Limited
Decision Date2011-12-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE THERMOMETER COVERS AND SHEATHS is the device name listed in this FDA 510(k) record. The listed applicant is Kang ZE Industrial Co. Limited. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K112289. 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 DISPOSABLE THERMOMETER COVERS AND SHEATHS?

DISPOSABLE THERMOMETER COVERS AND SHEATHS is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Kang ZE Industrial Co. Limited. The 510(k) number is K112289.

When did DISPOSABLE THERMOMETER COVERS AND SHEATHS receive FDA 510(k) clearance?

DISPOSABLE THERMOMETER COVERS AND SHEATHS received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112289.

Who is the listed applicant for DISPOSABLE THERMOMETER COVERS AND SHEATHS?

The FDA 510(k) record lists Kang ZE Industrial Co. Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE THERMOMETER COVERS AND SHEATHS?

The FDA product code for DISPOSABLE THERMOMETER COVERS AND SHEATHS 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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