Cleared Special

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM

K010031 · Wescor, Inc. · Physical Medicine
Mar 2001
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K010031 is an FDA 510(k) clearance for the NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM, 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 March 20, 2001, 76 days after receiving the submission on January 3, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K010031 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2001
Decision Date March 20, 2001
Days to Decision 76 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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