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FDA 510(k)

OLEA SPHERE

K-Number: K132095 · 2013-12-26

ApplicantOlea Medical
Decision Date2013-12-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLEA SPHERE is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2013-12-26 under 510(k) number K132095. 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?

OLEA SPHERE is a medical device that received FDA 510(k) clearance on 2013-12-26. The listed applicant is Olea Medical. The 510(k) number is K132095.

When did OLEA SPHERE receive FDA 510(k) clearance?

OLEA SPHERE received FDA 510(k) clearance on 2013-12-26, under 510(k) number K132095.

Who is the listed applicant for OLEA SPHERE?

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?

The FDA product code for OLEA SPHERE is LLZ.

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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.

K223091CT Perfusion V1.0K223532Olea S.I.A. Neurovascular V1.0K230552MR DWI/FLAIR Measurement V1.0K223502MR Diffusion Perfusion Mismatch V1.0K211431breastscape v1.0K152602Olea Sphere V3.0

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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.

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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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