ATOM 1 (MODEL: BRC 2200)— 510(k) K121578

Name: FDA 510(k) clearance K121578
Creator: U.S. Food and Drug Administration
Published: 2012-07-31

Substantially Equivalent

Bioelectric Research Corporation

FDA 510(k) clearance K121578 for ATOM 1 (MODEL: BRC 2200), Substantially Equivalent on 2012-07-31. Applicant: Bioelectric Research Corporation. Device class: 2.

Clearance details

Applicant: Bioelectric Research Corporation
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2012-05-30
Decision date: 2012-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carson City, NV, US

Download summary PDF View on FDA.gov ↗

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