The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Srs (semi-resuable Sensor).
| Device ID | K050313 |
| 510k Number | K050313 |
| Device Name: | BIS SRS (SEMI-RESUABLE SENSOR) |
| Classification | Pinwheel |
| Applicant | ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. Newton, MA 02464 |
| Contact | Christine Vozella |
| Product Code | GWY |
| CFR Regulation Number | 882.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-02-24 |
| Summary: | summary |