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FDA 510(k)

DIGITAL FOREHEAD THERMOMETER

K-Number: K103617 · 2011-04-04

Decision Date2011-04-04
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGITAL FOREHEAD THERMOMETER 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 2011-04-04 under 510(k) number K103617. 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 DIGITAL FOREHEAD THERMOMETER?

DIGITAL FOREHEAD THERMOMETER is a medical device that received FDA 510(k) clearance on 2011-04-04. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K103617.

When did DIGITAL FOREHEAD THERMOMETER receive FDA 510(k) clearance?

DIGITAL FOREHEAD THERMOMETER received FDA 510(k) clearance on 2011-04-04, under 510(k) number K103617.

Who is the listed applicant for DIGITAL FOREHEAD THERMOMETER?

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 DIGITAL FOREHEAD THERMOMETER?

The FDA product code for DIGITAL FOREHEAD THERMOMETER is FLL.

Related Clinical Trials

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.

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.

View all 25 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

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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