The following data is part of a premarket notification filed by Arion Water, Inc. with the FDA for Biopure Portable Ro Systems.
| Device ID | K112331 |
| 510k Number | K112331 |
| Device Name: | BIOPURE PORTABLE RO SYSTEMS |
| Classification | Subsystem, Water Purification |
| Applicant | ARION WATER, INC. 1 COMMERCE WAY BLDG 1 UNIT C Carver, MA 02330 |
| Contact | Robert Livingstion |
| Correspondent | Robert Livingstion ARION WATER, INC. 1 COMMERCE WAY BLDG 1 UNIT C Carver, MA 02330 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2012-07-05 |
| Summary: | summary |