ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI

Purifier, Air, Ultraviolet, Medical

HGI INDUSTIRES

The following data is part of a premarket notification filed by Hgi Industires with the FDA for Odorox(r) Idu/rx (tm) In-duct Models, Odorox(r) Idu/rx (tm) Mobile Disinfection Units, Odorox(r) Slimline/rx (tm) Slimli.

Pre-market Notification Details

Device IDK133800
510k NumberK133800
Device Name:ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
ClassificationPurifier, Air, Ultraviolet, Medical
Applicant HGI INDUSTIRES 2055 HIGH RIDGE ROAD Boynton Beach,  FL  33426
ContactConnie Araps, Phd
CorrespondentConnie Araps, Phd
HGI INDUSTIRES 2055 HIGH RIDGE ROAD Boynton Beach,  FL  33426
Product CodeFRA  
CFR Regulation Number880.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-13
Decision Date2014-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00819355020218 K133800 000

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