K935958 is an FDA 510(k) clearance for the CRIT-LINE BLOOD CHAMBER WITH E-BEAM. This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II - Special Controls, product code KOC).
Submitted by In-Line Diagnostics Corp. (Riverdale, US). The FDA issued a Cleared decision on January 19, 1995, 419 days after receiving the submission on November 26, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K935958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1993 |
| Decision Date | January 19, 1995 |
| Days to Decision | 419 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |