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FDA 510(k)

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

K-Number: K070458 · 2007-12-21

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2007-12-21
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Diagnostics (Bmd) SA. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K070458. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO FIDIS VASCULITIS, MODEL MX007?

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K070458.

When did MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 receive FDA 510(k) clearance?

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 received FDA 510(k) clearance on 2007-12-21, under 510(k) number K070458.

Who is the listed applicant for MODIFICATION TO FIDIS VASCULITIS, MODEL MX007?

The FDA 510(k) record lists Biomedical Diagnostics (Bmd) SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO FIDIS VASCULITIS, MODEL MX007?

The FDA product code for MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 is MOB.

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Other records listing Biomedical Diagnostics (Bmd) SA as applicant

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Related Devices (Code: MOB)

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.

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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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