K940601 is an FDA 510(k) clearance for the GAMBRO BICART 720G. This device is classified as a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II - Special Controls, product code KPO).
Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 22, 1994, 40 days after receiving the submission on February 10, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K940601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1994 |
| Decision Date | March 22, 1994 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |