The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Hp M2376a Device Link System, Model M2376a.
| Device ID | K002009 |
| 510k Number | K002009 |
| Device Name: | HP M2376A DEVICE LINK SYSTEM, MODEL M2376A |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD., MS 0491 Andover, MA 01810 -1099 |
| Contact | Mike Hudon |
| Correspondent | Mike Hudon AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD., MS 0491 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 | 2000-07-03 |
| Decision Date | 2000-08-02 |