Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K062388 |
Device Name |
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM |
Applicant |
DOCUSYS |
820 SOUTH UNIVERSITY BLVD |
SUITE 3-H |
MOBILE,
AL
36609
|
|
Applicant Contact |
GORDON J PETERS |
Correspondent |
DOCUSYS |
820 SOUTH UNIVERSITY BLVD |
SUITE 3-H |
MOBILE,
AL
36609
|
|
Correspondent Contact |
GORDON J PETERS |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 08/15/2006 |
Decision Date | 02/22/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|