K984194 is an FDA 510(k) clearance for the HP M2376A DEVICE LINK SYSTEM, a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on April 30, 1999, 158 days after receiving the submission on November 23, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K984194 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 23, 1998 |
| Decision Date | April 30, 1999 |
| Days to Decision | 158 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 |