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FDA 510(k)

Medline Digital Thermometer Non-Lubricated Probe Sheath

K-Number: K211931 · 2021-09-20

ApplicantMedline Industries, Inc.
Decision Date2021-09-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medline Digital Thermometer Non-Lubricated Probe Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K211931. 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 Medline Digital Thermometer Non-Lubricated Probe Sheath?

Medline Digital Thermometer Non-Lubricated Probe Sheath is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Medline Industries, Inc.. The 510(k) number is K211931.

When did Medline Digital Thermometer Non-Lubricated Probe Sheath receive FDA 510(k) clearance?

Medline Digital Thermometer Non-Lubricated Probe Sheath received FDA 510(k) clearance on 2021-09-20, under 510(k) number K211931.

Who is the listed applicant for Medline Digital Thermometer Non-Lubricated Probe Sheath?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Digital Thermometer Non-Lubricated Probe Sheath?

The FDA product code for Medline Digital Thermometer Non-Lubricated Probe Sheath 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

View on FDA Database →

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