Cleared Traditional

Z-NET

K001003 · Demite Limited · General Hospital
Dec 2001
Decision
621d
Days
Class 1
Risk

About This 510(k) Submission

K001003 is an FDA 510(k) clearance for the Z-NET, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Demite Limited (Washington, US). The FDA issued a Cleared decision on December 10, 2001, 621 days after receiving the submission on March 29, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number K001003 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2000
Decision Date December 10, 2001
Days to Decision 621 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMW — Cover, Mattress (medical Purposes)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6190

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