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FDA 510(k)

Probe Covers for Thermometers

K-Number: K180714 · 2018-09-24

Decision Date2018-09-24
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Probe Covers for Thermometers is the device name listed in this FDA 510(k) record. The listed applicant is K-Jump Health Co., Ltd.. It received FDA 510(k) clearance on 2018-09-24 under 510(k) number K180714. 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 for Thermometers?

Probe Covers for Thermometers is a medical device that received FDA 510(k) clearance on 2018-09-24. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K180714.

When did Probe Covers for Thermometers receive FDA 510(k) clearance?

Probe Covers for Thermometers received FDA 510(k) clearance on 2018-09-24, under 510(k) number K180714.

Who is the listed applicant for Probe Covers for Thermometers?

The FDA 510(k) record lists K-Jump Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Probe Covers for Thermometers?

The FDA product code for Probe Covers for Thermometers is FLL.

Other records listing K-Jump Health 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.

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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