FDA 510(k)

IVD-GE02

K-Number: K101947 · 2011-03-16

Decision Date2011-03-16

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IVD-GE02 is the device name listed in this FDA 510(k) record. The listed applicant is Sphere Medical , Ltd.. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K101947. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVD-GE02?

IVD-GE02 is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Sphere Medical , Ltd.. The 510(k) number is K101947.

When did IVD-GE02 receive FDA 510(k) clearance?

IVD-GE02 received FDA 510(k) clearance on 2011-03-16, under 510(k) number K101947.

Who is the listed applicant for IVD-GE02?

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

What is the FDA product code for IVD-GE02?

The FDA product code for IVD-GE02 is CGA.

Related Devices (Code: CGA)

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

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