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FDA 510(k)

HEALTHANYWHERE SYSTEM

K-Number: K091220 · 2009-09-21

Decision Date2009-09-21
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEALTHANYWHERE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthanywhere, an Igeacare System Company. It received FDA 510(k) clearance on 2009-09-21 under 510(k) number K091220. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHANYWHERE SYSTEM?

HEALTHANYWHERE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-21. The listed applicant is Healthanywhere, an Igeacare System Company. The 510(k) number is K091220.

When did HEALTHANYWHERE SYSTEM receive FDA 510(k) clearance?

HEALTHANYWHERE SYSTEM received FDA 510(k) clearance on 2009-09-21, under 510(k) number K091220.

Who is the listed applicant for HEALTHANYWHERE SYSTEM?

The FDA 510(k) record lists Healthanywhere, an Igeacare System Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTHANYWHERE SYSTEM?

The FDA product code for HEALTHANYWHERE SYSTEM is DRG.

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.

Related Devices (Code: DRG)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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