Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K002001 |
Device Name |
BREEZE SLEEPGEAR WITH DREAMSEAL |
Applicant |
PURITAN BENNETT CORP. |
2800 NORTHWEST BLVD. |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
DARIN BUSCH |
Correspondent |
PURITAN BENNETT CORP. |
2800 NORTHWEST BLVD. |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
DARIN BUSCH |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/30/2000 |
Decision Date | 09/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|