HALO
K-Number: K200873 · 2020-11-20
ApplicantNico-Lab B.V.
Decision Date2020-11-20
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HALO is a medical device manufactured by Nico-Lab B.V.. It received FDA 510(k) clearance on 2020-11-20 under approval number K200873. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HALO?
HALO is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Nico-Lab B.V.. The 510(k) number is K200873.
When was HALO approved by the FDA?
HALO received FDA 510(k) clearance on 2020-11-20, under approval number K200873.
What company makes HALO?
HALO is manufactured by Nico-Lab B.V..
What is the FDA product code for HALO?
The FDA product code for HALO is QAS.
Other Devices by Nico-Lab B.V.
Related Devices (Code: QAS)
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.