Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BF-NAVI

K-Number: K093810 · 2010-06-18

ApplicantKgt, Inc.
Decision Date2010-06-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BF-NAVI is the device name listed in this FDA 510(k) record. The listed applicant is Kgt, Inc.. It received FDA 510(k) clearance on 2010-06-18 under 510(k) number K093810. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BF-NAVI?

BF-NAVI is a medical device that received FDA 510(k) clearance on 2010-06-18. The listed applicant is Kgt, Inc.. The 510(k) number is K093810.

When did BF-NAVI receive FDA 510(k) clearance?

BF-NAVI received FDA 510(k) clearance on 2010-06-18, under 510(k) number K093810.

Who is the listed applicant for BF-NAVI?

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

What is the FDA product code for BF-NAVI?

The FDA product code for BF-NAVI is JAK.

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.

↑