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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 a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-09-20 under approval 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. It is manufactured by Medline Industries, Inc.. The 510(k) number is K211931.

When was Medline Digital Thermometer Non-Lubricated Probe Sheath approved by the FDA?

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

What company makes Medline Digital Thermometer Non-Lubricated Probe Sheath?

Medline Digital Thermometer Non-Lubricated Probe Sheath is manufactured by Medline Industries, Inc..

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.

Related PubMed Literature

PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

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Related Devices (Code: 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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