Orion LifeSpan MEG
K-Number: K191785 · 2020-02-14
ApplicantCompumedics Limited
Decision Date2020-02-14
Product CodeOLY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Orion LifeSpan MEG is a medical device manufactured by Compumedics Limited. It received FDA 510(k) clearance on 2020-02-14 under approval 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. It is manufactured by Compumedics Limited. The 510(k) number is K191785.
When was Orion LifeSpan MEG approved by the FDA?
Orion LifeSpan MEG received FDA 510(k) clearance on 2020-02-14, under approval number K191785.
What company makes Orion LifeSpan MEG?
Orion LifeSpan MEG is manufactured by Compumedics Limited.
What is the FDA product code for Orion LifeSpan MEG?
The FDA product code for Orion LifeSpan MEG is OLY.
Other Devices by Compumedics Limited
Related Devices (Code: OLY)
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.