J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS— 510(k) K945826

Name: FDA 510(k) clearance K945826
Creator: U.S. Food and Drug Administration
Published: 1995-08-04

Substantially Equivalent

Medical Device Inspection Co., Inc.

FDA 510(k) clearance K945826 for J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS, Substantially Equivalent on 1995-08-04. Applicant: Medical Device Inspection Co., Inc.. Device class: 2.

Clearance details

Applicant: Medical Device Inspection Co., Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1994-11-29
Decision date: 1995-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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