The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Local Report Generator.
| Device ID | K904318 |
| 510k Number | K904318 |
| Device Name: | LOCAL REPORT GENERATOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1990-12-18 |