The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Spacelabs Smart Disclosure System.
| Device ID | K110779 |
| 510k Number | K110779 |
| Device Name: | SPACELABS SMART DISCLOSURE SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522123580 | K110779 | 000 |
| 10841522123597 | K110779 | 000 |