NAVIO
K-Number: K191223 · 2019-06-28
ApplicantBlue Belt Technologies, Inc.
Decision Date2019-06-28
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NAVIO is a medical device manufactured by Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-28 under approval number K191223. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NAVIO?
NAVIO is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Blue Belt Technologies, Inc.. The 510(k) number is K191223.
When was NAVIO approved by the FDA?
NAVIO received FDA 510(k) clearance on 2019-06-28, under approval number K191223.
What company makes NAVIO?
NAVIO is manufactured by Blue Belt Technologies, Inc..
What is the FDA product code for NAVIO?
The FDA product code for NAVIO is OLO.
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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.