Device Classification Name |
Burn Resuscitation Decision Support Software
|
510(k) Number |
K121659 |
Device Name |
BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) |
Applicant |
ARCOS, INC. |
866 W. 41ST |
HOUSTON,
TX
77018
|
|
Applicant Contact |
CHRIS MEADOR |
Correspondent |
ARCOS, INC. |
866 W. 41ST |
HOUSTON,
TX
77018
|
|
Correspondent Contact |
CHRIS MEADOR |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 06/05/2012 |
Decision Date | 04/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|