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FDA 510(k)

Disposable Ear Thermometer Probe Cover

K-Number: K203431 · 2021-07-28

ApplicantHuaian Zhongxin Packing Material Co., Ltd.
Decision Date2021-07-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Ear Thermometer Probe Cover is a medical device manufactured by Huaian Zhongxin Packing Material Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under approval number K203431. 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 Ear Thermometer Probe Cover?

Disposable Ear Thermometer Probe Cover is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Huaian Zhongxin Packing Material Co., Ltd.. The 510(k) number is K203431.

When was Disposable Ear Thermometer Probe Cover approved by the FDA?

Disposable Ear Thermometer Probe Cover received FDA 510(k) clearance on 2021-07-28, under approval number K203431.

What company makes Disposable Ear Thermometer Probe Cover?

Disposable Ear Thermometer Probe Cover is manufactured by Huaian Zhongxin Packing Material Co., Ltd..

What is the FDA product code for Disposable Ear Thermometer Probe Cover?

The FDA product code for Disposable Ear Thermometer Probe Cover is FLL.

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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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