The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Pediatric Sensor.
| Device ID | K041670 |
| 510k Number | K041670 |
| Device Name: | BIS PEDIATRIC SENSOR |
| Classification | Electrode, Cutaneous |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
| Contact | Renee Gould |
| Correspondent | N.e. Devine, Jr. ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-21 |
| Decision Date | 2004-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521134546 | K041670 | 000 |
| 20884521134338 | K041670 | 000 |
| 10884521128538 | K041670 | 000 |