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FDA 510(k)

Probe Covers (YF-001, YF-002)

K-Number: K240023 · 2024-03-01

ApplicantShenzhen YI Fang Blister Packaging Co., Ltd.
Decision Date2024-03-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Probe Covers (YF-001, YF-002) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen YI Fang Blister Packaging Co., Ltd.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K240023. 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 Probe Covers (YF-001, YF-002)?

Probe Covers (YF-001, YF-002) is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Shenzhen YI Fang Blister Packaging Co., Ltd.. The 510(k) number is K240023.

When did Probe Covers (YF-001, YF-002) receive FDA 510(k) clearance?

Probe Covers (YF-001, YF-002) received FDA 510(k) clearance on 2024-03-01, under 510(k) number K240023.

Who is the listed applicant for Probe Covers (YF-001, YF-002)?

The FDA 510(k) record lists Shenzhen YI Fang Blister Packaging Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Probe Covers (YF-001, YF-002)?

The FDA product code for Probe Covers (YF-001, YF-002) 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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