Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K131790 |
Device Name |
A9800 ANESTHESIA WORKSTATION |
Applicant |
ORICARE, INC. |
1900 AM DRIVE |
QUAKERTOWN,
PA
18951
|
|
Applicant Contact |
KURTIS MONTEGNA |
Correspondent |
ORICARE, INC. |
1900 AM DRIVE |
QUAKERTOWN,
PA
18951
|
|
Correspondent Contact |
KURTIS MONTEGNA |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 06/18/2013 |
Decision Date | 05/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|