Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K001646 |
Device Name |
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION |
Applicant |
PURITAN BENNETT CORP. |
2200 FARADAY AVE. |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
MARY E FUNK |
Correspondent |
PURITAN BENNETT CORP. |
2200 FARADAY AVE. |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
MARY E FUNK |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 05/30/2000 |
Decision Date | 10/20/2000 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|