Cleared Traditional

WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER

K863395 · Wescor, Inc. · Toxicology
May 1988
Decision
629d
Days
Class 2
Risk

About This 510(k) Submission

K863395 is an FDA 510(k) clearance for the WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on May 24, 1988, 629 days after receiving the submission on September 3, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K863395 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1986
Decision Date May 24, 1988
Days to Decision 629 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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