The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp M2376a Device Link System.
| Device ID | K993587 |
| 510k Number | K993587 |
| Device Name: | HP M2376A DEVICE LINK SYSTEM |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Mike Hudon |
| Correspondent | Mike Hudon HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 2000-01-20 |
| Summary: | summary |