The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for A-line Aep Monitor.
| Device ID | K010965 |
| 510k Number | K010965 |
| Device Name: | A-LINE AEP MONITOR |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Renee Fluet |
| Correspondent | Renee Fluet ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Product Code | OLW |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-06-27 |