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 |