Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
510(k) Number |
K050153 |
Device Name |
SPIRIT, MODEL HAS |
Applicant |
CAIRE, INC. |
1800 SANDY PLAINS INDUSTRIAL |
PARKWAY, SUITE 316 |
MARIETTA,
GA
30066
|
|
Applicant Contact |
DAN CHLAN |
Correspondent |
CAIRE, INC. |
1800 SANDY PLAINS INDUSTRIAL |
PARKWAY, SUITE 316 |
MARIETTA,
GA
30066
|
|
Correspondent Contact |
DAN CHLAN |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 01/24/2005 |
Decision Date | 04/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|