The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110.
| Device ID | K001980 |
| 510k Number | K001980 |
| Device Name: | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 |
| Classification | Electrode, Cutaneous |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
| Contact | Christine M Vozella |
| Correspondent | Christine M Vozella ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-29 |
| Decision Date | 2000-09-27 |