510(k) K133800
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI by
Hgi Industires
— Product Code FRA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- December 13, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Purifier, Air, Ultraviolet, Medical
- Device Class
- Class II
- Regulation Number
- 880.6500
- Review Panel
- HO
- Submission Type