Device Classification Name |
oximeter
|
510(k) Number |
K060576 |
Device Name |
NELLCOR OXIMAX N-600X PULSE OXIMETER |
Applicant |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Applicant Contact |
PATRICK GARVEY |
Correspondent |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Correspondent Contact |
PATRICK GARVEY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/06/2006 |
Decision Date | 08/14/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|