The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for M2376a Devicelink System, Model M2376a.
| Device ID | K014181 |
| 510k Number | K014181 |
| Device Name: | M2376A DEVICELINK SYSTEM, MODEL M2376A |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. MS 0491 Andover, MA 01810 -1099 |
| Contact | Mike Hudon |
| Correspondent | Mike Hudon PHILIPS MEDICAL SYSTEMS, 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 | 2001-12-20 |
| Decision Date | 2002-01-15 |
| Summary: | summary |