The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Full Disclosure System, Model 91810.
| Device ID | K063490 |
| 510k Number | K063490 |
| Device Name: | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-03-15 |
| Summary: | summary |