Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K092847 |
Device Name |
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION |
Applicant |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
Jean Simon |
Correspondent |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
Jean Simon |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/16/2009 |
Decision Date | 03/11/2010 |
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
|
|
|