The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for M2376a Devicelink System.
| Device ID | K003107 |
| 510k Number | K003107 |
| Device Name: | M2376A DEVICELINK SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Mike Hudon |
| Correspondent | Mike Hudon AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-04 |
| Decision Date | 2000-10-19 |