K972470 is an FDA 510(k) clearance for the CRIT-LINE MONITOR (CLMIII), a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by In-Line Diagnostics Corp. (Great Neck, US). The FDA issued a Cleared decision on December 11, 1997, 163 days after receiving the submission on July 1, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K972470 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1997 |
| Decision Date | December 11, 1997 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQS — System, Hemodialysis, Access Recirculation Monitoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |