HALO
K-Number: K211788 · 2021-07-08
ApplicantNicolab B.V.
Decision Date2021-07-08
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HALO is a medical device manufactured by Nicolab B.V.. It received FDA 510(k) clearance on 2021-07-08 under approval number K211788. 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 2021-07-08. It is manufactured by Nicolab B.V.. The 510(k) number is K211788.
When was HALO approved by the FDA?
HALO received FDA 510(k) clearance on 2021-07-08, under approval number K211788.
What company makes HALO?
HALO is manufactured by Nicolab B.V..
What is the FDA product code for HALO?
The FDA product code for HALO is QAS.
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.