The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Zipprep Electrode.
| Device ID | K940802 |
| 510k Number | K940802 |
| Device Name: | ZIPPREP ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 770 COCHITUATE RD. Framingham, MA 01710 -9331 |
| Contact | Christine Morgida |
| Correspondent | Christine Morgida ASPECT MEDICAL SYSTEMS, INC. 770 COCHITUATE RD. Framingham, MA 01710 -9331 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-06-22 |