The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical 90482 Bispectral Index Analysis (bis) Module.
| Device ID | K973596 |
| 510k Number | K973596 |
| Device Name: | SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond, WA 98052 |
| Contact | Russ Garrison |
| Correspondent | Russ Garrison SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond, WA 98052 |
| Product Code | OLW |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1998-02-03 |
| Summary: | summary |