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FDA 510(k)

PERFSCAPE

K-Number: K091444 · 2009-07-20

ApplicantOlea Medical
Decision Date2009-07-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PERFSCAPE is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2009-07-20 under 510(k) number K091444. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFSCAPE?

PERFSCAPE is a medical device that received FDA 510(k) clearance on 2009-07-20. The listed applicant is Olea Medical. The 510(k) number is K091444.

When did PERFSCAPE receive FDA 510(k) clearance?

PERFSCAPE received FDA 510(k) clearance on 2009-07-20, under 510(k) number K091444.

Who is the listed applicant for PERFSCAPE?

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 PERFSCAPE?

The FDA product code for PERFSCAPE is LNH.

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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: LNH)

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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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