The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Agilent Information Center Software For M3150,m3151,m3153 And M3154.
| Device ID | K011093 |
| 510k Number | K011093 |
| Device Name: | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Dave Osborn |
| Correspondent | Dave Osborn AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-10 |
| Decision Date | 2001-05-01 |