Cleared Traditional

K853973 - WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
(FDA 510(k) Clearance)

K853973 · Wescor, Inc. · Physical Medicine
Oct 1985
Decision
20d
Days
Class 2
Risk

K853973 is an FDA 510(k) clearance for the WESCOR MODEL 3700 WEBSTER SWEAT INDUCER, a Device, Iontophoresis, Specific Uses (Class II — Special Controls, product code KTB), submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on October 16, 1985, 20 days after receiving the submission on September 26, 1985. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K853973 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1985
Decision Date October 16, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code KTB — Device, Iontophoresis, Specific Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525