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FDA 510(k)

APPS-HEALTH01

K-Number: K122098 · 2013-03-21

ApplicantAndon Health Co, Ltd.
Decision Date2013-03-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPS-HEALTH01 is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K122098. 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 APPS-HEALTH01?

APPS-HEALTH01 is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K122098.

When did APPS-HEALTH01 receive FDA 510(k) clearance?

APPS-HEALTH01 received FDA 510(k) clearance on 2013-03-21, under 510(k) number K122098.

Who is the listed applicant for APPS-HEALTH01?

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

What is the FDA product code for APPS-HEALTH01?

The FDA product code for APPS-HEALTH01 is DXN.

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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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