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FDA 510(k)

MEDIBYTE, MODEL MP8

K-Number: K061764 · 2006-09-06

ApplicantBraebon Medical Corp.
Decision Date2006-09-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDIBYTE, MODEL MP8 is the device name listed in this FDA 510(k) record. The listed applicant is Braebon Medical Corp.. It received FDA 510(k) clearance on 2006-09-06 under 510(k) number K061764. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIBYTE, MODEL MP8?

MEDIBYTE, MODEL MP8 is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Braebon Medical Corp.. The 510(k) number is K061764.

When did MEDIBYTE, MODEL MP8 receive FDA 510(k) clearance?

MEDIBYTE, MODEL MP8 received FDA 510(k) clearance on 2006-09-06, under 510(k) number K061764.

Who is the listed applicant for MEDIBYTE, MODEL MP8?

The FDA 510(k) record lists Braebon Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIBYTE, MODEL MP8?

The FDA product code for MEDIBYTE, MODEL MP8 is MNR.

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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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