Device Classification Name |
oximeter
|
510(k) Number |
K120773 |
Device Name |
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM |
Applicant |
Covidien LLC |
77325 JOYCE WAY |
ECHO,
OR
97826 -.
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
Covidien LLC |
77325 JOYCE WAY |
ECHO,
OR
97826 -.
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/14/2012 |
Decision Date | 07/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|