Device Classification Name |
oximeter
|
510(k) Number |
K061329 |
Device Name |
INFINITY MASIMO SET SP02 POD |
Applicant |
Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Applicant Contact |
THOMAS MCINTOSH |
Correspondent |
Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
THOMAS MCINTOSH |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/12/2006 |
Decision Date | 07/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|