FDA 510(k)

Z-NET

K-Number: K001003 · 2001-12-10

Decision Date2001-12-10

Product CodeFMW

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Z-NET is the device name listed in this FDA 510(k) record. The listed applicant is Demite Limited. It received FDA 510(k) clearance on 2001-12-10 under 510(k) number K001003. The device is classified under product code FMW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-NET?

Z-NET is a medical device that received FDA 510(k) clearance on 2001-12-10. The listed applicant is Demite Limited. The 510(k) number is K001003.

When did Z-NET receive FDA 510(k) clearance?

Z-NET received FDA 510(k) clearance on 2001-12-10, under 510(k) number K001003.

Who is the listed applicant for Z-NET?

The FDA 510(k) record lists Demite Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z-NET?

The FDA product code for Z-NET is FMW.

Related Devices (Code: FMW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152884DermaTherapy Bed LinensPrecision Fabrics Group, Inc.K061242DERMATHERAPY, MODEL 22216Precision Fabrics Group, Inc.K992702EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEMAllergy Direct K940327INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOWW. L. Gore & Associates, Inc.K935220CORE PREVENT MATTRESS MODIFICATIONPaladin Medical, Inc.K924807REUSABLE INCONTIENT UNDERPADPerfect Fit Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.