Device Classification Name |
unit, liquid-oxygen, portable
|
510(k) Number |
K080023 |
Device Name |
MODIFICATION TO: SPIRIT |
Applicant |
CAIRE, INC. |
1800 SANDY PLAINS INDUSTRIAL |
PARKWAY, STE.316 |
MARIETTA,
GA
30066
|
|
Applicant Contact |
ZULFIQAR A CHOUDARY |
Correspondent |
CAIRE, INC. |
1800 SANDY PLAINS INDUSTRIAL |
PARKWAY, STE.316 |
MARIETTA,
GA
30066
|
|
Correspondent Contact |
ZULFIQAR A CHOUDARY |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 01/04/2008 |
Decision Date | 06/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|