AsoAligner
K-Number: K201104 · 2021-02-26
ApplicantAso International Manila, Inc.
Decision Date2021-02-26
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AsoAligner is a medical device manufactured by Aso International Manila, Inc.. It received FDA 510(k) clearance on 2021-02-26 under approval number K201104. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AsoAligner?
AsoAligner is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Aso International Manila, Inc.. The 510(k) number is K201104.
When was AsoAligner approved by the FDA?
AsoAligner received FDA 510(k) clearance on 2021-02-26, under approval number K201104.
What company makes AsoAligner?
AsoAligner is manufactured by Aso International Manila, Inc..
What is the FDA product code for AsoAligner?
The FDA product code for AsoAligner is NXC.
Related Devices (Code: NXC)
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.