The following data is part of a premarket notification filed by Dayton Water Systems with the FDA for Aseptech Portable Ro+ System.
| Device ID | K924695 |
| 510k Number | K924695 |
| Device Name: | ASEPTECH PORTABLE RO+ SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | DAYTON WATER SYSTEMS 1288 MCCOOK AVE. Dayton, OH 45404 |
| Contact | Diane Dolan |
| Correspondent | Diane Dolan DAYTON WATER SYSTEMS 1288 MCCOOK AVE. Dayton, OH 45404 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-17 |
| Decision Date | 1995-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817927020215 | K924695 | 000 |