Device Classification Name |
Oximeter
|
510(k) Number |
K121806 |
Device Name |
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE |
Applicant |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
ELIZABETH MALO |
Correspondent |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
ELIZABETH MALO |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/20/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|