Cleared Traditional

S&W TYPE 888 ELECTRODE

K861158 · National Medical Technology · Cardiovascular
Jul 1986
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K861158 is an FDA 510(k) clearance for the S&W TYPE 888 ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by National Medical Technology (Orlando, US). The FDA issued a Cleared decision on July 1, 1986, 95 days after receiving the submission on March 28, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K861158 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1986
Decision Date July 01, 1986
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

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