The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extrapure Reverse Osmosis Water Unit.
| Device ID | K822385 |
| 510k Number | K822385 |
| Device Name: | EXTRAPURE REVERSE OSMOSIS WATER UNIT |
| Classification | Subsystem, Water Purification |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-09 |
| Decision Date | 1982-10-13 |