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FDA 510(k)

DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200

K-Number: K070491 · 2007-06-21

ApplicantK-Jump Health Co., Ltd.
Decision Date2007-06-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 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 2007-06-21 under 510(k) number K070491. 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, MODEL# KD-2200?

DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 is a medical device that received FDA 510(k) clearance on 2007-06-21. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K070491.

When did DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 receive FDA 510(k) clearance?

DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 received FDA 510(k) clearance on 2007-06-21, under 510(k) number K070491.

Who is the listed applicant for DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200?

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, MODEL# KD-2200?

The FDA product code for DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 is FLL.

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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.

K180714Probe Covers for ThermometersK170262Digital ThermometerK121520ULTRASONIC NEBULIZER (MESH TYPE)K120711NON-CONTACT THERMOMETERK103617DIGITAL FOREHEAD THERMOMETERK102947NON-CONTACT INFRARED THERMOMETER

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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.

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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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