The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Spacelabs Arkon Anesthesia Workstation.
Device ID | K113051 |
510k Number | K113051 |
Device Name: | SPACELABS ARKON ANESTHESIA WORKSTATION |
Classification | Ventilator, Continuous, Facility Use |
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 | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-13 |
Decision Date | 2012-03-22 |
Summary: | summary |