Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K113633 |
Device Name |
MCKESSON ANESTHESIA CARE |
Applicant |
MCKESSON TECHNOLOGIES INC. |
1835 MARKET STREET |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE M HOGAN |
Correspondent |
MCKESSON TECHNOLOGIES INC. |
1835 MARKET STREET |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 12/08/2011 |
Decision Date | 04/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|