The following data is part of a premarket notification filed by Medionics International Ltd. with the FDA for C.a.p.d. Automatic Heater Pdh 200.
| Device ID | K842305 |
| 510k Number | K842305 |
| Device Name: | C.A.P.D. AUTOMATIC HEATER PDH 200 |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | MEDIONICS INTERNATIONAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-12 |
| Decision Date | 1984-06-25 |