Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K-Number: K232344 · 2023-10-11
ApplicantGE Medical Systems SCS
Decision Date2023-10-11
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2023-10-11 under approval number K232344. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR?
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by GE Medical Systems SCS. The 510(k) number is K232344.
When was Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR approved by the FDA?
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR received FDA 510(k) clearance on 2023-10-11, under approval number K232344.
What company makes Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR?
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR is manufactured by GE Medical Systems SCS.
What is the FDA product code for Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR?
The FDA product code for Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR is OWB.
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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.