The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Aspect Medical Systems Zipprep Eeg Sensor.
| Device ID | K961821 |
| 510k Number | K961821 |
| Device Name: | ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR |
| Classification | Electrode, Cutaneous |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 2 VISION DR. Natick, MA 01760 -2059 |
| Contact | Christine Morgida |
| Correspondent | Christine Morgida ASPECT MEDICAL SYSTEMS, INC. 2 VISION DR. Natick, MA 01760 -2059 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1996-10-04 |
| Summary: | summary |