The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Bispectral Index (bisx) Analysis Module 91482 And Accessories Model-91842.
| Device ID | K060900 |
| 510k Number | K060900 |
| Device Name: | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa, WA 98027 -7018 |
| Contact | Al Van Houdt |
| Correspondent | Al Van Houdt SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa, WA 98027 -7018 |
| 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 | 2006-04-03 |
| Decision Date | 2006-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522100253 | K060900 | 000 |