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FDA 510(k)

Olea Sphere V3.0

K-Number: K152602 · 2016-03-03

ApplicantOlea Medical
Decision Date2016-03-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Olea Sphere V3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K152602. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Olea Sphere V3.0?

Olea Sphere V3.0 is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Olea Medical. The 510(k) number is K152602.

When did Olea Sphere V3.0 receive FDA 510(k) clearance?

Olea Sphere V3.0 received FDA 510(k) clearance on 2016-03-03, under 510(k) number K152602.

Who is the listed applicant for Olea Sphere V3.0?

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

What is the FDA product code for Olea Sphere V3.0?

The FDA product code for Olea Sphere V3.0 is LLZ.

Other records listing Olea Medical as applicant

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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Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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