The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for St/ar St And Arrhythmia Software, Model Release D.0.
| Device ID | K003621 |
| 510k Number | K003621 |
| Device Name: | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 |
| 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 | 2000-11-24 |
| Decision Date | 2000-12-20 |