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FDA 510(k)

BRC SOFTWARE PRODUCT

K-Number: K050192 · 2005-10-20

ApplicantBrc Operations Pty Limited
Decision Date2005-10-20
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRC SOFTWARE PRODUCT is the device name listed in this FDA 510(k) record. The listed applicant is Brc Operations Pty Limited. It received FDA 510(k) clearance on 2005-10-20 under 510(k) number K050192. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRC SOFTWARE PRODUCT?

BRC SOFTWARE PRODUCT is a medical device that received FDA 510(k) clearance on 2005-10-20. The listed applicant is Brc Operations Pty Limited. The 510(k) number is K050192.

When did BRC SOFTWARE PRODUCT receive FDA 510(k) clearance?

BRC SOFTWARE PRODUCT received FDA 510(k) clearance on 2005-10-20, under 510(k) number K050192.

Who is the listed applicant for BRC SOFTWARE PRODUCT?

The FDA 510(k) record lists Brc Operations Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRC SOFTWARE PRODUCT?

The FDA product code for BRC SOFTWARE PRODUCT is OLU.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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