Cleared Traditional

SPECTRA R PAD

K791013 · Parker Laboratories, Inc. · Neurology
Sep 1979
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K791013 is an FDA 510(k) clearance for the SPECTRA R PAD, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979, 108 days after receiving the submission on June 1, 1979. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K791013 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1979
Decision Date September 17, 1979
Days to Decision 108 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GYB — Media, Electroconductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1275