Device Classification Name |
Attachment, Breathing, Positive End Expiratory Pressure
|
510(k) Number |
K860848 |
Device Name |
VITAL FLOW NASAL CPAP SYSTEM |
Applicant |
SYSTEMS 2000, INC. |
ATTORNEY AT LAW |
2085 RUSTIN AVENUE |
RIVERSIDE,
CA
92507
|
|
Applicant Contact |
STANLEY E FRY |
Correspondent |
SYSTEMS 2000, INC. |
ATTORNEY AT LAW |
2085 RUSTIN AVENUE |
RIVERSIDE,
CA
92507
|
|
Correspondent Contact |
STANLEY E FRY |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 03/06/1986 |
Decision Date | 06/12/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|