Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K162738 |
Device Name |
Puritan Bennett 980 Ventilator System |
Applicant |
Covidien |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Applicant Contact |
Kelsey Lee |
Correspondent |
Covidien |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Correspondent Contact |
Kelsey Lee |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/30/2016 |
Decision Date | 10/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|