Device Classification Name |
Attachment, Breathing, Positive End Expiratory Pressure
|
510(k) Number |
K861104 |
Device Name |
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR |
Applicant |
MED AIR TECHNOLOGY, INC. |
2519 E. KEARNEY |
SPRINGFIELD,
MO
65803
|
|
Applicant Contact |
LOIS A HANSEN |
Correspondent |
MED AIR TECHNOLOGY, INC. |
2519 E. KEARNEY |
SPRINGFIELD,
MO
65803
|
|
Correspondent Contact |
LOIS A HANSEN |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 03/24/1986 |
Decision Date | 04/28/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|