Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K131502 |
Device Name |
SEATTLE - PAP |
Applicant |
SEATTLE CHILDRENS HOSPITAL |
1900 NINTH AVENUE |
SEATTLE,
WA
98101
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
SEATTLE CHILDRENS HOSPITAL |
1900 NINTH AVENUE |
SEATTLE,
WA
98101
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 05/24/2013 |
Decision Date | 10/11/2013 |
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
|
|
|