Device Classification Name |
Mixer, Breathing Gases, Anesthesia Inhalation
|
510(k) Number |
K990293 |
Device Name |
ALADDIN II MONITORING OXYGEN/AIR MONITOR |
Applicant |
HAMILTON MEDICAL, INC. |
3371 LENORA CHURCH RD. |
SNELLVILLE,
GA
30039
|
|
Applicant Contact |
TIMOTHY Y COWART |
Correspondent |
HAMILTON MEDICAL, INC. |
3371 LENORA CHURCH RD. |
SNELLVILLE,
GA
30039
|
|
Correspondent Contact |
TIMOTHY Y COWART |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 01/29/1999 |
Decision Date | 03/16/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|