The following data is part of a premarket notification filed by Flier's Quality Water Systems Inc with the FDA for Acute Portable Exchange Deionization (pedi) System, Central Pedi System, Back-up Pedi System.
| Device ID | K071104 |
| 510k Number | K071104 |
| Device Name: | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | FLIER'S QUALITY WATER SYSTEMS INC 7425 CLYDE PARK AVENUE SW SUITE A Byron Center, MI 49315 |
| Contact | James Flier |
| Correspondent | James Flier FLIER'S QUALITY WATER SYSTEMS INC 7425 CLYDE PARK AVENUE SW SUITE A Byron Center, MI 49315 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-19 |
| Decision Date | 2008-01-14 |
| Summary: | summary |