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FDA 510(k)

YUWELL infrared ear thermometer: YHT101, YHT200

K-Number: K203583 · 2021-05-20

Decision Date2021-05-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YUWELL infrared ear thermometer: YHT101, YHT200 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203583. 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 YUWELL infrared ear thermometer: YHT101, YHT200?

YUWELL infrared ear thermometer: YHT101, YHT200 is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K203583.

When did YUWELL infrared ear thermometer: YHT101, YHT200 receive FDA 510(k) clearance?

YUWELL infrared ear thermometer: YHT101, YHT200 received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203583.

Who is the listed applicant for YUWELL infrared ear thermometer: YHT101, YHT200?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YUWELL infrared ear thermometer: YHT101, YHT200?

The FDA product code for YUWELL infrared ear thermometer: YHT101, YHT200 is FLL.

Other records listing Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as applicant

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.

View all 13 devices →

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.

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.