Aksys, Ltd. · Class II · Cleared Mar 26, 2002
| K-number | K010131 |
| Device name | PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB |
| Applicant | Aksys, Ltd. |
| Product code | KDI |
| Device class | Class II |
| Decision date | Mar 26, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 876.5860 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov