Cleared Traditional

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS

K945826 · Medical Device Inspection Co., Inc. · Neurology
Aug 1995
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K945826 is an FDA 510(k) clearance for the J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on August 4, 1995, 248 days after receiving the submission on November 29, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K945826 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1994
Decision Date August 04, 1995
Days to Decision 248 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050