Device Classification Name |
Oximeter
|
510(k) Number |
K172482 |
Device Name |
The Nellcor pulse oximetry monitor interface cable |
Applicant |
Covidien |
6135 Gunbarrel Avenue |
Boulder,
CO
80301
|
|
Applicant Contact |
Mia M. Ware |
Correspondent |
Covidien |
6135 Gunbarrel Avenue |
Boulder,
CO
80301
|
|
Correspondent Contact |
Mia M. Ware |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/16/2017 |
Decision Date | 12/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|