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FDA 510(k)

ATOM 1 (MODEL: BRC 2200)

K-Number: K121578 · 2012-07-31

ApplicantBioelectric Research Corporation
Decision Date2012-07-31
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ATOM 1 (MODEL: BRC 2200) is the device name listed in this FDA 510(k) record. The listed applicant is Bioelectric Research Corporation. It received FDA 510(k) clearance on 2012-07-31 under 510(k) number K121578. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATOM 1 (MODEL: BRC 2200)?

ATOM 1 (MODEL: BRC 2200) is a medical device that received FDA 510(k) clearance on 2012-07-31. The listed applicant is Bioelectric Research Corporation. The 510(k) number is K121578.

When did ATOM 1 (MODEL: BRC 2200) receive FDA 510(k) clearance?

ATOM 1 (MODEL: BRC 2200) received FDA 510(k) clearance on 2012-07-31, under 510(k) number K121578.

Who is the listed applicant for ATOM 1 (MODEL: BRC 2200)?

The FDA 510(k) record lists Bioelectric Research Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATOM 1 (MODEL: BRC 2200)?

The FDA product code for ATOM 1 (MODEL: BRC 2200) is GZJ.

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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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