Cleared Traditional

RICH-MAR CARBON ELECTRODES

K950491 · Rich-Mar Corp. · Neurology
Mar 1995
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K950491 is an FDA 510(k) clearance for the RICH-MAR CARBON ELECTRODES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on March 29, 1995, 51 days after receiving the submission on February 6, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K950491 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1995
Decision Date March 29, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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