K864094 is an FDA 510(k) clearance for the GAMBRO FLUID CONTROL MONITOR FCM 10-1. This device is classified as a System, Dialysate Delivery, Single Patient (Class II - Special Controls, product code FKP).
Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on November 7, 1986, 17 days after receiving the submission on October 21, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K864094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1986 |
| Decision Date | November 07, 1986 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |