FDA 510(k)

HEC 1000

K-Number: K020466 · 2002-05-08

Decision Date2002-05-08

Product CodeKPJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEC 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Metro Medical Equipment, Inc.. It received FDA 510(k) clearance on 2002-05-08 under 510(k) number K020466. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEC 1000?

HEC 1000 is a medical device that received FDA 510(k) clearance on 2002-05-08. The listed applicant is Metro Medical Equipment, Inc.. The 510(k) number is K020466.

When did HEC 1000 receive FDA 510(k) clearance?

HEC 1000 received FDA 510(k) clearance on 2002-05-08, under 510(k) number K020466.

Who is the listed applicant for HEC 1000?

The FDA 510(k) record lists Metro Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEC 1000?

The FDA product code for HEC 1000 is KPJ.

Related Devices (Code: KPJ)

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.

K250188Wound Treatment System (VHT-200)Vaporox, Inc.K212121VHT-200 Wound Treatment SystemVaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba Ogenix K112634NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.K120764EPIFLO(R)Neogenix, LLC K090681TANSCU O2Electrochemical Oxygen Concepts, 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.