The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Zipprep Electrode.
| Device ID | K070069 |
| 510k Number | K070069 |
| Device Name: | ZIPPREP ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 1 UPLAND ROAD Norwood, MA 02062 |
| Contact | Vikram Verma |
| Correspondent | Vikram Verma ASPECT MEDICAL SYSTEMS, INC. 1 UPLAND ROAD Norwood, MA 02062 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-08 |
| Decision Date | 2007-02-05 |
| Summary: | summary |