The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Agilent Information Center Software For M3150a And M3153a And Agilent M2/m3/m4 Compact Portable Patient Monitor.
| Device ID | K001057 |
| 510k Number | K001057 |
| Device Name: | AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-03 |
| Decision Date | 2000-05-03 |