Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K120075 |
Device Name |
AM-6000 ANESTHESIA MACHINE |
Applicant |
ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 ST |
HIALEAH,
FL
33010
|
|
Applicant Contact |
JORGE MILLAN |
Correspondent |
ADVANCED INSTRUMENTATIONS, INC. |
601 WEST 20 ST |
HIALEAH,
FL
33010
|
|
Correspondent Contact |
JORGE MILLAN |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 01/10/2012 |
Decision Date | 01/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|