The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90480 Eeg Module.
| Device ID | K896942 |
| 510k Number | K896942 |
| Device Name: | SPACELABS MODEL 90480 EEG MODULE |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Raymond W Gifford |
| Correspondent | Raymond W Gifford SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-03-08 |