Device Classification Name |
oximeter
|
510(k) Number |
K123581 |
Device Name |
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN |
Applicant |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
6135 Gunbarrel Ave |
BOULDER,
CO
80301
|
|
Applicant Contact |
MIA M WARE |
Correspondent |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
6135 Gunbarrel Ave |
BOULDER,
CO
80301
|
|
Correspondent Contact |
MIA M WARE |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 11/20/2012 |
Decision Date | 05/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|