FDA 510(k)

Orion LifeSpan MEG

K-Number: K191785 · 2020-02-14

Decision Date2020-02-14

Product CodeOLY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Orion LifeSpan MEG is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K191785. The device is classified under product code OLY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orion LifeSpan MEG?

Orion LifeSpan MEG is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Compumedics Limited. The 510(k) number is K191785.

When did Orion LifeSpan MEG receive FDA 510(k) clearance?

Orion LifeSpan MEG received FDA 510(k) clearance on 2020-02-14, under 510(k) number K191785.

Who is the listed applicant for Orion LifeSpan MEG?

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

What is the FDA product code for Orion LifeSpan MEG?

The FDA product code for Orion LifeSpan MEG is OLY.

Other records listing Compumedics Limited 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.

K252383Somfit D K242447Falcon HST K231546Somfit K230073Okti

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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.