Apollo Duet (Model : APD-4000)
K-Number: K212253 · 2022-08-25
ApplicantWeero Co.
Decision Date2022-08-25
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Apollo Duet (Model : APD-4000) is a medical device manufactured by Weero Co.. It received FDA 510(k) clearance on 2022-08-25 under approval number K212253. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Apollo Duet (Model : APD-4000)?
Apollo Duet (Model : APD-4000) is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Weero Co.. The 510(k) number is K212253.
When was Apollo Duet (Model : APD-4000) approved by the FDA?
Apollo Duet (Model : APD-4000) received FDA 510(k) clearance on 2022-08-25, under approval number K212253.
What company makes Apollo Duet (Model : APD-4000)?
Apollo Duet (Model : APD-4000) is manufactured by Weero Co..
What is the FDA product code for Apollo Duet (Model : APD-4000)?
The FDA product code for Apollo Duet (Model : APD-4000) is PBX.
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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.