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FDA 510(k)

MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822

K-Number: K043531 · 2005-04-21

ApplicantK-Jump Health Co., Ltd.
Decision Date2005-04-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 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 2005-04-21 under 510(k) number K043531. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822?

MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K043531.

When did MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 receive FDA 510(k) clearance?

MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 received FDA 510(k) clearance on 2005-04-21, under 510(k) number K043531.

Who is the listed applicant for MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822?

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 MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822?

The FDA product code for MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 is DXN.

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Other records listing K-Jump Health Co., Ltd. as applicant

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Related Devices (Code: DXN)

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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