Cleared Traditional

SYS MACRODUCT SWEAT COLLECTION SYS 3600

K840472 · Wescor, Inc. · Physical Medicine
Mar 1984
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K840472 is an FDA 510(k) clearance for the SYS MACRODUCT SWEAT COLLECTION SYS 3600, a Device, Iontophoresis, Specific Uses (Class II — Special Controls, product code KTB), submitted by Wescor, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984, 45 days after receiving the submission on February 3, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K840472 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1984
Decision Date March 19, 1984
Days to Decision 45 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