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 |