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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) 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. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K191223.

When did NAVIO receive FDA 510(k) clearance?

NAVIO received FDA 510(k) clearance on 2019-06-28, under 510(k) number K191223.

Who is the listed applicant for NAVIO?

The FDA 510(k) record lists Blue Belt Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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