ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI— 510(k) K133800

Name: FDA 510(k) clearance K133800
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Substantially Equivalent

Hgi Industires

FDA 510(k) clearance K133800 for ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI, Substantially Equivalent on 2014-12-19. Applicant: Hgi Industires. Device class: 2.

Clearance details

Applicant: Hgi Industires
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2013-12-13
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boynton Beach, FL, US

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