The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Click Sensor/cable.
| Device ID | K091854 |
| 510k Number | K091854 |
| Device Name: | BIS CLICK SENSOR/CABLE |
| Classification | Electrode, Cutaneous |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. ONE UPLAND ROAD Norwood, MA 02062 |
| Contact | Vikram Verma |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-19 |
| Decision Date | 2009-07-02 |
| Summary: | summary |