PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421— 510(k) K875308

Name: FDA 510(k) clearance K875308
Creator: U.S. Food and Drug Administration
Published: 1988-02-26

Substantially Equivalent

Self Regulation Systems, Inc.

FDA 510(k) clearance K875308 for PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421, Substantially Equivalent on 1988-02-26. Applicant: Self Regulation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Self Regulation Systems, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1987-12-29
Decision date: 1988-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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