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 |