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.
| Device ID | K133800 |
| 510k Number | K133800 |
| Device Name: | ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | HGI INDUSTIRES 2055 HIGH RIDGE ROAD Boynton Beach, FL 33426 |
| Contact | Connie Araps, Phd |
| Correspondent | Connie Araps, Phd HGI INDUSTIRES 2055 HIGH RIDGE ROAD Boynton Beach, FL 33426 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819355020218 | K133800 | 000 |