BOSS
K-Number: K223700 · 2024-08-16
ApplicantIntelon Optics, Inc.
Decision Date2024-08-16
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
BOSS is a medical device manufactured by Intelon Optics, Inc.. It received FDA 510(k) clearance on 2024-08-16 under approval number K223700. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BOSS?
BOSS is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Intelon Optics, Inc.. The 510(k) number is K223700.
When was BOSS approved by the FDA?
BOSS received FDA 510(k) clearance on 2024-08-16, under approval number K223700.
What company makes BOSS?
BOSS is manufactured by Intelon Optics, Inc..
What is the FDA product code for BOSS?
The FDA product code for BOSS is MXK.
Related Devices (Code: MXK)
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.