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FDA 510(k)

BMR FACE

K-Number: K103031 · 2011-11-10

ApplicantBio-Medical Research, Ltd.
Decision Date2011-11-10
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BMR FACE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K103031. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BMR FACE?

BMR FACE is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K103031.

When did BMR FACE receive FDA 510(k) clearance?

BMR FACE received FDA 510(k) clearance on 2011-11-10, under 510(k) number K103031.

Who is the listed applicant for BMR FACE?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMR FACE?

The FDA product code for BMR FACE is NFO.

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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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