Device Classification Name |
Oximeter
|
510(k) Number |
K201179 |
Device Name |
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable |
Applicant |
Covidien llc |
6135 Gunbarrel Avenue |
Boulder,
CO
80301
|
|
Applicant Contact |
Ligia Mastronardi |
Correspondent |
Covidien llc |
6135 Gunbarrel Avenue |
Boulder,
CO
80301
|
|
Correspondent Contact |
Ligia Mastronardi |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/01/2020 |
Decision Date | 07/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|