The following data is part of a premarket notification filed by Simply Clean Air & Water, Inc. with the FDA for Acute Portable Exchange Deionization (pedi) System, Central Pedi System, Back-up Pedi System.
| Device ID | K042018 |
| 510k Number | K042018 |
| Device Name: | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | SIMPLY CLEAN AIR & WATER, INC. 28 SHEPARD DRIVE Newington, CT 06131 |
| Contact | Raymond Kowalec |
| Correspondent | Raymond Kowalec SIMPLY CLEAN AIR & WATER, INC. 28 SHEPARD DRIVE Newington, CT 06131 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-27 |
| Decision Date | 2005-04-15 |
| Summary: | summary |