The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Quatro Sensor.
| Device ID | K093183 |
| 510k Number | K093183 |
| Device Name: | BIS QUATRO SENSOR |
| Classification | Electrode, Cutaneous |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 1 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 | 2009-10-09 |
| Decision Date | 2009-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521134505 | K093183 | 000 |
| 10884521133884 | K093183 | 000 |
| 90884521211267 | K093183 | 000 |
| 90884521722961 | K093183 | 000 |
| 10884521134317 | K093183 | 000 |
| 10884521134324 | K093183 | 000 |