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FDA 510(k)

IHEALTH CLOUD

K-Number: K131203 · 2013-07-19

ApplicantAndon Health Co, Ltd.
Decision Date2013-07-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IHEALTH CLOUD 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 2013-07-19 under 510(k) number K131203. 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 IHEALTH CLOUD?

IHEALTH CLOUD is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K131203.

When did IHEALTH CLOUD receive FDA 510(k) clearance?

IHEALTH CLOUD received FDA 510(k) clearance on 2013-07-19, under 510(k) number K131203.

Who is the listed applicant for IHEALTH CLOUD?

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 IHEALTH CLOUD?

The FDA product code for IHEALTH CLOUD 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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